Cleared Traditional

CARESIDE TOTAL BILIRUBIN

K981588 · Careside, Inc. · Chemistry
Jun 1998
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K981588 is an FDA 510(k) clearance for the CARESIDE TOTAL 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 June 23, 1998, 50 days after receiving the submission on May 4, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K981588 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1998
Decision Date June 23, 1998
Days to Decision 50 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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