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Cobas Reagent for Calcium

by Hoffmann-La Roche, Inc.

510(k) K823577

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 NumberK823577 Date7 Jan 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  • Withdrawn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
CIC
Device Class
Class II
Regulation
21 CFR Part 862.1145
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 reagent for the quantitative determination of calcium in human serum, plasma, and urine. It is intended for use on cobas c systems as an in vitro diagnostic test.

The reagent is supplied for use in clinical chemistry laboratories and is regulated under FDA 510(k) clearance K823577, classified as a Class II device with product code CIC. It is substantially equivalent to a legally marketed device and was cleared via the traditional 510(k) pathway on January 7, 1983.

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Questions

AI-generated answers, 1 Oct 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 the COBAS REAGENT FOR CALCIUM used for?

    The COBAS REAGENT FOR CALCIUM is used for the quantitative determination of calcium in human serum, plasma, and urine as an in vitro diagnostic test on cobas c systems in clinical chemistry laboratories.

  • How is the COBAS REAGENT FOR CALCIUM supplied and intended for use?

    The reagent is supplied for use in clinical chemistry laboratories and is intended for use on cobas c systems as an in vitro diagnostic test for measuring calcium levels in human serum, plasma, and urine specimens.

  • What regulatory pathway was used for the COBAS REAGENT FOR CALCIUM and what is its classification?

    The COBAS REAGENT FOR CALCIUM was cleared via the traditional 510(k) pathway under FDA 510(k) clearance K823577 and is classified as a Class II device with product code CIC, based on its substantial equivalence to a legally marketed device.