510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K852320Substantially Equivalent

Cobas Fp Reagen for Procainamide & Pro Calibrator

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

K852320 is the FDA 510(k) clearance record for COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code LAR (Enzyme Immunoassay, Procainamide). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K852320.

Clearance record

Decision date
Received
(39 days to decision)
Product code
LAR Enzyme Immunoassay, Procainamide
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. Div. Of Hoffmann-La Roche, Inc, Nutley NJ
Third party review
No

Clearances, product code LAR

Trailing 12 months

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

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