Cleared Traditional

SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406

K932159 · Em Diagnostic Systems, Inc. · Chemistry
Sep 1993
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K932159 is an FDA 510(k) clearance for the SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406, 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 September 21, 1993, 140 days after receiving the submission on May 4, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K932159 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1993
Decision Date September 21, 1993
Days to Decision 140 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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