Cleared Traditional

COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS

K936130 · Roche Diagnostic Systems, Inc. · Toxicology
Mar 1994
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K936130 is an FDA 510(k) clearance for the COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS, a Fluorescence Polarization Immunoassay, Phenobarbital (Class II — Special Controls, product code LGQ), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on March 11, 1994, 78 days after receiving the submission on December 23, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K936130 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1993
Decision Date March 11, 1994
Days to Decision 78 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

Similar Devices — LGQ Fluorescence Polarization Immunoassay, Phenobarbital

All 11
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K972331 · Oxis Intl., Inc. · Aug 1997
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
K972330 · Oxis Intl., Inc. · Jul 1997
AXSYM PHENOBARBITAL
K940596 · Abbott Laboratories · Jun 1994
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704 · Innotron of Oregon, Inc. · Apr 1990
FPR PHENOBARBITAL KIT
K894525 · Colony Laboratories, Inc. · Aug 1989
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397 · Roche Diagnostic Systems, Inc. · Jul 1987