Cleared Traditional

TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS

K884224 · A-Kem, Inc. · Chemistry
Dec 1988
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K884224 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on December 15, 1988, 70 days after receiving the submission on October 6, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K884224 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1988
Decision Date December 15, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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