Cleared Traditional

TOTAL BILIRUBIN

K931888 · Em Diagnostic Systems, Inc. · Chemistry
Jul 1993
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K931888 is an FDA 510(k) clearance for the TOTAL BILIRUBIN, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on July 27, 1993, 103 days after receiving the submission on April 15, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K931888 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1993
Decision Date July 27, 1993
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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