QUANTASE PHENYLALANINE ASSAY— 510(k) K961515

Name: FDA 510(k) clearance K961515
Creator: U.S. Food and Drug Administration
Published: 1996-06-12

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K961515 for QUANTASE PHENYLALANINE ASSAY, Substantially Equivalent on 1996-06-12. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1996-04-10
Decision date: 1996-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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