Cleared Traditional

COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.

K872397 · Roche Diagnostic Systems, Inc. · Toxicology
Jul 1987
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K872397 is an FDA 510(k) clearance for the COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI., a Fluorescence Polarization Immunoassay, Phenobarbital (Class II — Special Controls, product code LGQ), submitted by Roche Diagnostic Systems, Inc. (Belleville, US). The FDA issued a Cleared decision on July 21, 1987, 29 days after receiving the submission on June 22, 1987. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K872397 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1987
Decision Date July 21, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LGQ — Fluorescence Polarization Immunoassay, Phenobarbital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3660

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