510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K964506Substantially Equivalent

Roche Cobas Amplicor Analyzer

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

K964506 is the FDA 510(k) clearance record for ROCHE COBAS AMPLICOR 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 one recall naming K964506.

Clearance record

Decision date
Received
(194 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. 1080 Us Hwy. 202, Branchburg NJ
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