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Cobas Fp Reagen for Primidone & Primi Calibrators

by Roche Diagnostic Systems, Inc.

510(k) K852318

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 NumberK852318 Date25 Jun 1985ClearedStatusActive

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  • Withdrawn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
LFT
Device Class
Class II
Regulation
21 CFR Part 862.3680
Advisory Committee
Clinical Toxicology
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.

This device is a fluorescent immunoassay for Primidone, classified under product code LFT and regulation number 862.3680. It is intended for use in clinical toxicology for the detection and quantification of Primidone and its metabolites.

It is supplied as reagents and calibrators for use with the COBAS FP system. The device received FDA 510(k) clearance K852318 on June 25, 1985, as a substantially equivalent device under traditional review. It is for in vitro diagnostic use only.

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