Cleared Traditional

BICARBONATE

K931887 · Em Diagnostic Systems, Inc. · Chemistry
Aug 1993
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K931887 is an FDA 510(k) clearance for the BICARBONATE, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 3, 1993, 110 days after receiving the submission on April 15, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K931887 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1993
Decision Date August 03, 1993
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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