Cleared Traditional

CRESOLPHTHALEIN COMPLEXONE, CALCIUM

K860664 · Amresco, Inc. · Chemistry
Jun 1986
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K860664 is an FDA 510(k) clearance for the CRESOLPHTHALEIN COMPLEXONE, CALCIUM, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on June 27, 1986, 123 days after receiving the submission on February 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K860664 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1986
Decision Date June 27, 1986
Days to Decision 123 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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