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C-Reactive Protein Immunoturbidimetric Kit & Crp Calibrator

by Randox Laboratories, Ltd.

510(k) K953212

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK953212 Date31 Jul 1995ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1286-2023 FDA Class II initiated 1 Feb 2023

    The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

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  • Withdrawn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
DCK
Device Class
Class II
Regulation
21 CFR Part 866.5270
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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