Cleared Traditional

SERUM BICARBONATE/CARBON DIOXIDE

K955302 · Data Medical Associates, Inc. · Chemistry
Feb 1996
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K955302 is an FDA 510(k) clearance for the SERUM BICARBONATE/CARBON DIOXIDE, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on February 29, 1996, 101 days after receiving the submission on November 20, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K955302 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1995
Decision Date February 29, 1996
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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