STRATUS PRIMIDONE FLUOROMETRIC ENZYME— 510(k) K904683

Name: FDA 510(k) clearance K904683
Creator: U.S. Food and Drug Administration
Published: 1990-11-28

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K904683 for STRATUS PRIMIDONE FLUOROMETRIC ENZYME, Substantially Equivalent on 1990-11-28. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LFT
Device class: Class 2
Regulation: 21 CFR 862.3680
Advisory panel: Clinical Toxicology
Date received: 1990-10-15
Decision date: 1990-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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