Cleared Traditional

TOTAL BILIRUBIN PROCEDURE

K955300 · Data Medical Associates, Inc. · Chemistry
Dec 1995
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K955300 is an FDA 510(k) clearance for the TOTAL BILIRUBIN PROCEDURE, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on December 20, 1995, 30 days after receiving the submission on November 20, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K955300 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1995
Decision Date December 20, 1995
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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