Cleared Traditional

GSP NEONATAL BIOTINIDASE KIT

K131284 · Wallac OY · Chemistry
Nov 2013
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K131284 is an FDA 510(k) clearance for the GSP NEONATAL BIOTINIDASE KIT, a System, Test, Biotinidase (Class II — Special Controls, product code NAK), submitted by Wallac OY (Waltham, US). The FDA issued a Cleared decision on November 14, 2013, 192 days after receiving the submission on May 6, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1118.

Submission Details

510(k) Number K131284 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2013
Decision Date November 14, 2013
Days to Decision 192 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NAK — System, Test, Biotinidase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1118