Cleared Traditional

MICROALBUMIN REAGENT SET AND CALIBRATORS

K023860 · Pointe Scientific, Inc., · Chemistry

Apr 2003

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K023860 is an FDA 510(k) clearance for the MICROALBUMIN REAGENT SET AND CALIBRATORS, a Albumin, Fitc, Antigen, Antiserum, Control (Class II — Special Controls, product code DDZ), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on April 28, 2003, 159 days after receiving the submission on November 20, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number	K023860 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2002
Decision Date	April 28, 2003
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement