Cleared Traditional

CARESIDE DIRECT BILIRUBIN

K993771 · Careside, Inc. · Chemistry
Dec 1999
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K993771 is an FDA 510(k) clearance for the CARESIDE DIRECT BILIRUBIN, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on December 27, 1999, 49 days after receiving the submission on November 8, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K993771 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1999
Decision Date December 27, 1999
Days to Decision 49 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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