Cleared Traditional

K993590 - FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
(FDA 510(k) Clearance)

K993590 · Pointe Scientific, Inc., · Chemistry

Dec 1999

Decision

60d

Days

Class 2

Risk

K993590 is an FDA 510(k) clearance for the FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on December 21, 1999, 60 days after receiving the submission on October 22, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K993590 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 1999
Decision Date	December 21, 1999
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement