Cleared Traditional

K940735 - LIQUID AMYLASE (CNPG3) REAGENT SET
(FDA 510(k) Clearance)

K940735 · Pointe Scientific, Inc., · Chemistry

Aug 1994

Decision

165d

Days

Class 2

Risk

K940735 is an FDA 510(k) clearance for the LIQUID AMYLASE (CNPG3) REAGENT SET. This device is classified as a Saccharogenic, Amylase (Class II — Special Controls, product code CIJ).

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on August 1, 1994, 165 days after receiving the submission on February 17, 1994.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number	K940735 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 1994
Decision Date	August 01, 1994
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement