QUANTASE PHENYLALANINE ASSAY— 510(k) K922547

Name: FDA 510(k) clearance K922547
Creator: U.S. Food and Drug Administration
Published: 1994-10-13

Substantially Equivalent

Porton Cambridge , Ltd.

FDA 510(k) clearance K922547 for QUANTASE PHENYLALANINE ASSAY, Substantially Equivalent on 1994-10-13. Applicant: Porton Cambridge , Ltd.. Device class: 2.

Clearance details

Applicant: Porton Cambridge , Ltd.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1992-06-01
Decision date: 1994-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cb8 7pw, United Kingdom, GB

Download summary PDF View on FDA.gov ↗

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