Cleared Traditional

K012332 - JAS CARBON DIOXIDE LIQUID REAGENT
(FDA 510(k) Clearance)

K012332 · Jas Diagnostics, Inc. · Chemistry

Sep 2001

Decision

45d

Days

Class 2

Risk

K012332 is an FDA 510(k) clearance for the JAS CARBON DIOXIDE LIQUID REAGENT, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on September 6, 2001, 45 days after receiving the submission on July 23, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number	K012332 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2001
Decision Date	September 06, 2001
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement