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OLYMPUS CRP LATEX REAGENT, OSR6199 - Olympus Crp Latex Calibrator High

by Olympus America, Inc.

510(k) K051564

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 NumberK051564 Date22 Aug 2005ClearedStatusActive

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  • Withdrawn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
NQD
Models / Variants
Olympus Crp Latex Calibrator High
Device Class
Class II
Regulation
21 CFR Part 866.5270
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Olympus CRP Latex Reagent and associated calibrators are cardiac C-reactive protein, antigen, antiserum, and control devices. These products are used in laboratory settings to facilitate the detection and measurement of C-reactive protein.

This device is supplied as a reagent and calibrator set for clinical use. It has received FDA 510(k) clearance under the regulation number 866.5270.

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