Home / 510(k) Clearances / K012966

510(k) K012966

ROCHE COBAS TAQMAN ANALYZER by Roche Molecular Systems, Inc. — Product Code JJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2002
Date Received
September 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

Other clearances by Roche Molecular Systems, Inc.

  • K243753 — cobas liat Bordetella panel nucleic acid test (November 20, 2025)
  • K252481 — cobas CMV (November 3, 2025)
  • K252484 — cobas HCV (November 3, 2025)
  • K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (July 31, 2025)
  • K243863 — Opulus™ Lymphoma Precision (May 30, 2025)
  • K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (April 25, 2025)
  • K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (April 25, 2025)
  • K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test (April 11, 2025)
  • K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (February 11, 2025)
  • K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)

Other clearances for product code JJF

  • K052794 — ETI-MAX 3000 (March 31, 2006)
  • K040332 — POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (June 16, 2004)
  • K033734 — LIGHTCYCLER INSTRUMENT VERSION 1.2 (December 17, 2003)
  • K013654 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (June 5, 2002)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (March 13, 1998)
  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K973177 — MAGO AUTOMATED EIA PROCESSOR (October 9, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)
  • K964506 — ROCHE COBAS AMPLICOR ANALYZER (May 21, 1997)