Cleared Traditional

REFLAB SYSTEM PACK LIQUID CO2 REAGENT

K926320 · Medical Analysis Systems, Inc. · Chemistry
Feb 1993
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K926320 is an FDA 510(k) clearance for the REFLAB SYSTEM PACK LIQUID CO2 REAGENT, a Coulometric Method, Carbon-dioxide (Class II — Special Controls, product code CHS), submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on February 3, 1993, 50 days after receiving the submission on December 15, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K926320 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1992
Decision Date February 03, 1993
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHS — Coulometric Method, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160