Cleared Traditional

K945523 - COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
(FDA 510(k) Clearance)

K945523 · Roche Diagnostic Systems, Inc. · Toxicology device

Mar 1995

Decision

119d

Days

Class 2

Risk

K945523 is an FDA 510(k) clearance for the COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS. This device is classified as a Fluorescent Immunoassay Gentamicin (Class II - Special Controls, product code LCQ).

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on March 9, 1995, 119 days after receiving the submission on November 10, 1994.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number	K945523 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 10, 1994
Decision Date	March 09, 1995
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement