Cleared Traditional

NEONATAL BIOTINIDASE KIT, MODEL 3018

K090123 · Perkinelmer, Inc. · Chemistry

Mar 2010

Decision

408d

Days

Class 2

Risk

About This 510(k) Submission

K090123 is an FDA 510(k) clearance for the NEONATAL BIOTINIDASE KIT, MODEL 3018, a System, Test, Biotinidase (Class II — Special Controls, product code NAK), submitted by Perkinelmer, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 5, 2010, 408 days after receiving the submission on January 21, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1118.

Submission Details

510(k) Number	K090123 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2009
Decision Date	March 05, 2010
Days to Decision	408 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF