Cleared Traditional

K925552 - HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
(FDA 510(k) Clearance)

K925552 · Hichem Diagnostics · Chemistry

Feb 1993

Decision

101d

Days

Class 2

Risk

K925552 is an FDA 510(k) clearance for the HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812, a Ph Rate Measurement, Carbon-dioxide (Class II — Special Controls, product code JFL), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on February 12, 1993, 101 days after receiving the submission on November 3, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number	K925552 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 1992
Decision Date	February 12, 1993
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement