510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K891581Substantially Equivalent

Cobas-Fp Reagent for Valproic Acid & Calibrators

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

K891581 is the FDA 510(k) clearance record for COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code LEG (Enzyme Immunoassay, Valproic Acid). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K891581.

Clearance record

Decision date
Received
(148 days to decision)
Product code
LEG Enzyme Immunoassay, Valproic Acid
Regulation
21 CFR 862.3645
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. One Sunset Ave., Montclair NJ
Third party review
No

Clearances, product code LEG

Trailing 12 months

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

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