Cleared Traditional

STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY

K934003 · Baxter Diagnostics, Inc. · Toxicology

Nov 1994

Decision

462d

Days

Class 2

Risk

About This 510(k) Submission

K934003 is an FDA 510(k) clearance for the STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY, a Antiserum, Digoxin (Class II — Special Controls, product code DKA), submitted by Baxter Diagnostics, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on November 22, 1994, 462 days after receiving the submission on August 17, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K934003 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 1993
Decision Date	November 22, 1994
Days to Decision	462 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF