Cleared Traditional

COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS

K952555 · Roche Diagnostic Systems, Inc. · Chemistry
Jul 1995
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K952555 is an FDA 510(k) clearance for the COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (free) (Class II — Special Controls, product code MOJ), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on July 31, 1995, 59 days after receiving the submission on June 2, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K952555 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1995
Decision Date July 31, 1995
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code MOJ — Fluorescence Polarization Immunoassay, Diphenylhydantoin (free)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350