QUANTASE TOTAL GALACTOSE SCREENING ASSAY— 510(k) K990644

Substantially Equivalent

Quantase , Ltd.

FDA 510(k) clearance K990644 for QUANTASE TOTAL GALACTOSE SCREENING ASSAY, Substantially Equivalent on 1999-06-21. Applicant: Quantase , Ltd..

Clearance details

Applicant: Quantase , Ltd.
Product code: Code JIA
Advisory panel: Clinical Chemistry
Date received: 1999-02-26
Decision date: 1999-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, Scotland, GB

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