Cleared Traditional

RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD

K883389 · Reagents Applications, Inc. · Chemistry
Dec 1988
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K883389 is an FDA 510(k) clearance for the RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD, a Calibrator, Surrogate (Class II — Special Controls, product code JIW), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on December 14, 1988, 126 days after receiving the submission on August 10, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K883389 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1988
Decision Date December 14, 1988
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIW — Calibrator, Surrogate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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