Cleared Traditional

RAICHEM(TM) BILIRUBIN STANDARD

K882726 · Reagents Applications, Inc. · Chemistry
Aug 1988
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K882726 is an FDA 510(k) clearance for the RAICHEM(TM) BILIRUBIN STANDARD, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on August 29, 1988, 59 days after receiving the submission on July 1, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K882726 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1988
Decision Date August 29, 1988
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIS — Calibrator, Primary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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