STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY— 510(k) K934003

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K934003 for STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1994-11-22. Applicant: Baxter Diagnostics, Inc..

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code DKA
Advisory panel: Clinical Toxicology
Date received: 1993-08-17
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

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