Cleared Traditional

HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813

K925553 · Hichem Diagnostics · Chemistry
Feb 1993
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K925553 is an FDA 510(k) clearance for the HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813, 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 K925553 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

Device Classification

Product Code JFL — Ph Rate Measurement, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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