Cleared Traditional

K973588 - LIQUID ALKALINE PHOSHATASE REAGENT SET
(FDA 510(k) Clearance)

K973588 · Pointe Scientific, Inc., · Chemistry

Oct 1997

Decision

30d

Days

Class 2

Risk

K973588 is an FDA 510(k) clearance for the LIQUID ALKALINE PHOSHATASE REAGENT SET. This device is classified as a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE).

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on October 22, 1997, 30 days after receiving the submission on September 22, 1997.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K973588 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 1997
Decision Date	October 22, 1997
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement