MANUAL PHENYLALANINE TEST— 510(k) K963040

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K963040 for MANUAL PHENYLALANINE TEST, Substantially Equivalent on 1996-10-01. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1996-08-05
Decision date: 1996-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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