Cleared Traditional

DIRECT BILIRUBIN

K003693 · Jas Diagnostics, Inc. · Chemistry
Jan 2001
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K003693 is an FDA 510(k) clearance for the DIRECT BILIRUBIN, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on January 29, 2001, 60 days after receiving the submission on November 30, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K003693 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2000
Decision Date January 29, 2001
Days to Decision 60 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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