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Stachrom Antiplasmin Test Kit

by American Bioproducts Co.

510(k) K882602

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882602 Date2 Sep 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GGP
Device Class
Class II
Regulation
21 CFR Part 864.7290
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Stachrom Antiplasmin Test Kit is a qualitative and quantitative assay used to evaluate antiplasmin factor deficiency. It is classified as a test device within the hematology specialty and is intended for laboratory analysis of blood samples to assess antiplasmin activity.

The kit is supplied as a complete test system and is regulated as a Class II medical device. It received traditional FDA 510(k) clearance (K882602) under product code GGP, indicating substantial equivalence to a predicate device. The device is intended for use in clinical laboratory settings and is listed under the Hematology advisory committee.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Stachrom Antiplasmin Test Kit used for?

    The Stachrom Antiplasmin Test Kit is used to evaluate antiplasmin factor deficiency through qualitative and quantitative assay in laboratory settings.

  • Is the Stachrom Antiplasmin Test Kit supplied as a complete system?

    Yes, the kit is supplied as a complete test system for laboratory analysis of blood samples to assess antiplasmin activity.

  • What type of medical device is the Stachrom Antiplasmin Test Kit classified as?

    The Stachrom Antiplasmin Test Kit is classified as a Class II medical device and is regulated as a test device within the hematology specialty.