Cleared Traditional

COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS

K936131 · Roche Diagnostic Systems, Inc. · Toxicology

Mar 1994

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K936131 is an FDA 510(k) clearance for the COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (Class II — Special Controls, product code LGR), 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 862.3350.

Submission Details

510(k) Number	K936131 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	LGR — Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3350