Cleared Traditional

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

K024006 · Pointe Scientific, Inc., · Chemistry

Mar 2003

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K024006 is an FDA 510(k) clearance for the G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE, a Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (Class II — Special Controls, product code JBF), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on March 31, 2003, 117 days after receiving the submission on December 4, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7360.

Submission Details

510(k) Number	K024006 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2002
Decision Date	March 31, 2003
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement