BIO-RAD CODA NEONATAL GALT ASSAY— 510(k) K993536

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K993536 for BIO-RAD CODA NEONATAL GALT ASSAY, Substantially Equivalent on 1999-11-04. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code KQP
Device class: Class 2
Regulation: 21 CFR 862.1315
Advisory panel: Clinical Chemistry
Date received: 1999-10-19
Decision date: 1999-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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