510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852318Substantially Equivalent

Cobas Fp Reagen for Primidone & Primi Calibrators

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

K852318 is the FDA 510(k) clearance record for COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code LFT (Fluorescent Immunoassay, Primidone). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K852318.

Clearance record

Decision date
Received
(25 days to decision)
Product code
LFT Fluorescent Immunoassay, Primidone
Regulation
21 CFR 862.3680
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 LFT

Trailing 12 months

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

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