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Accutex CRP Latex Test

by J.S. Medical Assoc. 510(k)

Active United States

510(k) K924332

Overview

The Accutex CRP Latex Test is a C-Reactive Protein, Antigen, Antiserum, and Control device used in immunology testing. It is a Class 2 medical device with product code DCK.

The device received FDA 510(k) clearance K924332 on December 7, 1992, through the Traditional pathway after a 102-day review. It is manufactured by J.S. Medical Assoc. and is substantially equivalent to a legally marketed predicate device.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924332 Date7 Dec 1992ClearedStatusActive

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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DCK
Device Class
Class II
Regulation
21 CFR Part 866.5270
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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See all devices from J.S. Medical Assoc. →

Questions

  • What is the Accutex CRP Latex Test used for?

    The Accutex CRP Latex Test is used in immunology testing to detect C-Reactive Protein as an antigen, utilizing antiserum and controls for laboratory analysis of inflammation markers.

  • How is the Accutex CRP Latex Test supplied and is it sterile?

    The device data does not specify the supply format, sterility, or single-use/reuse status of the Accutex CRP Latex Test; these details are not included in the provided authorization or specifications.

  • What regulatory pathway was used for the Accutex CRP Latex Test clearance?

    The Accutex CRP Latex Test received FDA 510(k) clearance through the Traditional pathway, with decision date December 7, 1992, under k-number K924332, based on substantial equivalence to a predicate device.