Cleared Traditional

CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432

K902479 · Amresco, Inc. · Chemistry
Jul 1990
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K902479 is an FDA 510(k) clearance for the CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on July 17, 1990, 42 days after receiving the submission on June 5, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K902479 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1990
Decision Date July 17, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIC — Cresolphthalein Complexone, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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