510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872397Substantially Equivalent

Cobas Fp Reagents for Pheno & Cobas Fp Pheno Cali.

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

K872397 is the FDA 510(k) clearance record for COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI., a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code LGQ (Fluorescence Polarization Immunoassay, Phenobarbital). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K872397.

Clearance record

Decision date
Received
(29 days to decision)
Product code
LGQ Fluorescence Polarization Immunoassay, Phenobarbital
Regulation
21 CFR 862.3660
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. 11 Franklin Ave., Belleville NJ
Third party review
No

Clearances, product code LGQ

Trailing 12 months

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

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