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Para Lasar

by Streck Laboratories, Inc.

510(k) K831094

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831094 Date8 Jun 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JPK
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

Para Lasar is a mixture hematology quality control device. It is substantially equivalent to a legally marketed device and received traditional 510(k) clearance from the FDA.

The device is supplied by Streck Laboratories, Inc. It is classified as a Class II medical device under product code JPK and regulation number 864.8625. The clearance was granted on June 8, 1983, under 510(k) number K831094.

Other devices from Streck Laboratories, Inc.

See all devices from Streck Laboratories, Inc. →

Questions

AI-generated answers, 28 Sep 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 Para Lasar used for?

    Para Lasar is a mixture hematology quality control device designed to monitor the accuracy and precision of hematology analyzers in laboratory testing, ensuring reliable performance of diagnostic equipment.

  • How is Para Lasar supplied and by whom?

    Para Lasar is supplied by Streck Laboratories, Inc., located at 803 N. Front St. Suite 3, McHenry, IL 60050, as a ready-to-use quality control mixture for hematology systems.

  • Is Para Lasar a single-use or reusable device?

    Para Lasar is intended for single-use quality control testing; it is not designed for reuse after initial application to prevent contamination and ensure consistent test results.

  • What regulatory pathway was used for Para Lasar?

    Para Lasar received traditional 510(k) clearance from the FDA, demonstrating substantial equivalence to a legally marketed predicate device under regulation number 864.8625 and product code JPK.