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

Name: FDA 510(k) clearance K984463
Creator: U.S. Food and Drug Administration
Published: 1999-02-16

Substantially Equivalent

Quantase , Ltd.

FDA 510(k) clearance K984463 for QUANTASE PHE/GAL SCREENING ASSAY, Substantially Equivalent on 1999-02-16. 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: 1998-12-16
Decision date: 1999-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, Scotland, GB

Download summary PDF View on FDA.gov ↗

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