STRATUS QUINIDINE FLUOROMETRIC ENZYME— 510(k) K843237

Name: FDA 510(k) clearance K843237
Creator: U.S. Food and Drug Administration
Published: 1984-09-12

Substantially Equivalent

American Dade

FDA 510(k) clearance K843237 for STRATUS QUINIDINE FLUOROMETRIC ENZYME, Substantially Equivalent on 1984-09-12. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code LBZ
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1984-08-22
Decision date: 1984-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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