QUANTASE PHE/GAL SCREENING ASSAY— 510(k) K984463

Substantially Equivalent

Quantase , Ltd.

FDA 510(k) clearance K984463 for QUANTASE PHE/GAL SCREENING ASSAY, Substantially Equivalent on 1999-02-16. Applicant: Quantase , Ltd..

Clearance details

Applicant: Quantase , Ltd.
Product code: Code JNB
Advisory panel: Clinical Chemistry
Date received: 1998-12-16
Decision date: 1999-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, Scotland, GB

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