Cleared Traditional

RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)

K880576 · Reagents Applications, Inc. · Chemistry
Jun 1988
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K880576 is an FDA 510(k) clearance for the RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID), a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on June 10, 1988, 121 days after receiving the submission on February 10, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K880576 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1988
Decision Date June 10, 1988
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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