510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896238Substantially Equivalent

Cobas Ready Ast Reagent

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

K896238 is the FDA 510(k) clearance record for COBAS READY AST REAGENT, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code CIS (Hydrazone Colorimetry, Ast/Sgot). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K896238.

Clearance record

Decision date
Received
(109 days to decision)
Product code
CIS Hydrazone Colorimetry, Ast/Sgot
Regulation
21 CFR 862.1100
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostic Systems, Inc. One Sunset Ave., Montclair NJ
Third party review
No

Clearances, product code CIS

Trailing 12 months

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

FDA records show no clearances under product code CIS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CIS, 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