Cleared Traditional

K974029 - ACS TOBRAMYCIN
(FDA 510(k) Clearance)

K974029 · Chiron Diagnostics Corp. · Toxicology

Feb 1998

Decision

112d

Days

Class 2

Risk

K974029 is an FDA 510(k) clearance for the ACS TOBRAMYCIN, a Fluorescent Immunoassay, Tobramycin (Class II — Special Controls, product code LCR), submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on February 12, 1998, 112 days after receiving the submission on October 23, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number	K974029 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 1997
Decision Date	February 12, 1998
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF