Cleared Special

BIO-RAD CODA NEONATAL GALT ASSAY

K993536 · Bio-Rad · Chemistry

Nov 1999

Decision

16d

Days

Class 2

Risk

About This 510(k) Submission

K993536 is an FDA 510(k) clearance for the BIO-RAD CODA NEONATAL GALT ASSAY, a Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase (Class II — Special Controls, product code KQP), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on November 4, 1999, 16 days after receiving the submission on October 19, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1315.

Submission Details

510(k) Number	K993536 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1999
Decision Date	November 04, 1999
Days to Decision	16 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	KQP — Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1315