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API Uniscept MIC

by Analytical Products, Inc. 510(k)

Active United States

510(k) K843732

Overview

The API Uniscept MIC is a Paraquat Assay device, designed for quantitative measurement of paraquat levels in biological samples. It employs analytical techniques to determine concentrations, supporting clinical or research applications where paraquat toxicity assessment is required.

This device is supplied as a reusable system and is intended for use in laboratory settings. It requires proper handling and storage per manufacturer guidelines, with no specific sterility claims noted. Authorized under FDA 510(k) clearance (K843732), it falls under Class III regulatory classification and is governed by traditional review processes. No MRI safety or single-use specifications are indicated in the available data.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843732 Date24 Oct 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LTD
Device Class
Class III
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the API Uniscept MIC used for in clinical or research settings?

    The API Uniscept MIC is specifically designed for quantitative measurement of paraquat levels in biological samples. This helps assess paraquat toxicity, which is critical in clinical or research contexts where exposure to this herbicide may require monitoring or evaluation of its effects on patients.

  • Is the API Uniscept MIC a single-use or reusable device, and how should it be stored?

    The API Uniscept MIC is supplied as a reusable system, meaning it can be used multiple times in laboratory settings. Storage should follow the manufacturer’s guidelines, though no specific sterility claims are mentioned, so proper handling and maintenance are essential to ensure accurate results.

  • What regulatory pathway does the API Uniscept MIC follow, and when was it cleared?

    The API Uniscept MIC was cleared through the FDA’s 510(k) process under Traditional Review, with a clearance date of October 24, 1984. It falls under Class III regulatory classification and is governed by the traditional review process, as indicated by its clearance number (K843732).

  • Does the API Uniscept MIC have any special considerations for use in MRI environments?

    The available data does not mention any MRI safety specifications for the API Uniscept MIC, so it should not be assumed safe for use in MRI environments. Clinicians should verify compatibility with their specific MRI systems before use.