QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT— 510(k) K000754

Name: FDA 510(k) clearance K000754
Creator: U.S. Food and Drug Administration
Published: 2000-06-19

Substantially Equivalent

Quantase , Ltd.

FDA 510(k) clearance K000754 for QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT, Substantially Equivalent on 2000-06-19. Applicant: Quantase , Ltd.. Device class: 2.

Clearance details

Applicant: Quantase , Ltd.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 2000-03-08
Decision date: 2000-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, Scotland, GB

Download summary PDF View on FDA.gov ↗

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