Cleared Traditional

I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE

K112430 · Abbott Pont of Care, Inc. · Chemistry

Dec 2011

Decision

118d

Days

Class 1

Risk

About This 510(k) Submission

K112430 is an FDA 510(k) clearance for the I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE, a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by Abbott Pont of Care, Inc. (Princton, US). The FDA issued a Cleared decision on December 20, 2011, 118 days after receiving the submission on August 24, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.

Submission Details

510(k) Number	K112430 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2011
Decision Date	December 20, 2011
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF