Cleared Special

MICROPLATE NEONATAL GALT ASSAY

K990827 · Bio-Rad · Chemistry

Apr 1999

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K990827 is an FDA 510(k) clearance for the MICROPLATE 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 April 9, 1999, 28 days after receiving the submission on March 12, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1315.

Submission Details

510(k) Number	K990827 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 1999
Decision Date	April 09, 1999
Days to Decision	28 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