Cleared Traditional

K974874 - BILIRUBIN-SL (TOTAL) ASSAY
(FDA 510(k) Clearance)

K974874 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry
Feb 1998
Decision
45d
Days
Class 2
Risk

K974874 is an FDA 510(k) clearance for the BILIRUBIN-SL (TOTAL) ASSAY, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on February 12, 1998, 45 days after receiving the submission on December 29, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K974874 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1997
Decision Date February 12, 1998
Days to Decision 45 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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