PHENYLALANINE UV KINETIC TEST KIT— 510(k) K813171

Name: FDA 510(k) clearance K813171
Creator: U.S. Food and Drug Administration
Published: 1981-12-03

Substantially Equivalent

Biochemicals, Inc.

FDA 510(k) clearance K813171 for PHENYLALANINE UV KINETIC TEST KIT, Substantially Equivalent on 1981-12-03. Applicant: Biochemicals, Inc.. Device class: 2.

Clearance details

Applicant: Biochemicals, Inc.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1981-11-16
Decision date: 1981-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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