510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012966Substantially Equivalent

Roche Cobas Taqman Analyzer

Roche Molecular Systems Inc, Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012966 is the FDA 510(k) clearance record for ROCHE COBAS TAQMAN ANALYZER, a class I device, cleared for Roche Molecular Systems, Inc. on under FDA product code JJF (Analyzer, Chemistry, Micro, For Clinical Use). FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show 3 recalls naming K012966.

Clearance record

Decision date
Received
(150 days to decision)
Product code
JJF Analyzer, Chemistry, Micro, For Clinical Use
Regulation
21 CFR 862.2170
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Roche Molecular Systems, Inc. 4300 Hacienda Dr., Pleasanton CA
510(k) summary
Summary
Third party review
No

Clearances, product code JJF

Trailing 12 months

FDA records hold no clearances under product code JJF in the trailing twelve months.

FDA records show no clearances under product code JJF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260