Cleared Traditional

BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30

K023330 · Diagnostic Chemicals , Ltd. · Chemistry
Dec 2002
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K023330 is an FDA 510(k) clearance for the BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on December 11, 2002, 68 days after receiving the submission on October 4, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K023330 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2002
Decision Date December 11, 2002
Days to Decision 68 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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