Cobas Core TSH EIA

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K930776 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Abuscreen(R) Radioimmun for Cocaine Metabolite

  Class II

  FDA 510(k) K913722 Active Cleared 10 Sep 1991

• Cobas Core Immunochemistry System

  Class I

  FDA 510(k) K962231 Active Cleared 30 Aug 1996

• Roche Reagent for Apolipoprotein B

  Class I

  FDA 510(k) K910552 Active Cleared 7 May 1991

• Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

  Class II

  FDA 510(k) K952337 Active Cleared 9 Feb 1996

• Roche Abuscreen Ontrak Pos. Ref. Control-Methadone

  Class I

  FDA 510(k) K930844 Active Cleared 27 Jan 1994

• Ontrak Testcup Amphetamines

  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

See all devices from Roche Diagnostic Systems, Inc. →

• What is the primary clinical use of the Cobas Core TSH EIA?

  This device is used for the determination of thyroid-stimulating hormone (TSH). It serves as a sensitive and specific parameter for assessing thyroid function and is utilized in the diagnosis of thyroid and pituitary disorders.

• What is the regulatory status of this device?

  The Cobas Core TSH EIA received FDA 510(k) clearance under K930776. It is classified under regulation number 862.1690 within the clinical chemistry medical specialty.

• Who is the manufacturer of this TSH testing device?

  The device is manufactured by Roche Diagnostic Systems, Inc., located in Branchburg, New Jersey.