PHENYLALANINE TEST KIT— 510(k) K943547

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K943547 for PHENYLALANINE TEST KIT, Substantially Equivalent on 1996-01-26. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1994-07-21
Decision date: 1996-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.