QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT— 510(k) K990654

Name: FDA 510(k) clearance K990654
Creator: U.S. Food and Drug Administration
Published: 1999-06-21

Substantially Equivalent

Quantase , Ltd.

FDA 510(k) clearance K990654 for QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT, Substantially Equivalent on 1999-06-21. Applicant: Quantase , Ltd.. Device class: 1.

Clearance details

Applicant: Quantase , Ltd.
Product code: Code JIA
Device class: Class 1
Regulation: 21 CFR 862.1310
Advisory panel: Clinical Chemistry
Date received: 1999-03-01
Decision date: 1999-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, Scotland, GB

Download summary PDF View on FDA.gov ↗

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