Cleared Traditional

ULTRA CHEM CRESOLCAVERSACHEM #65082

K830238 · Emd Chemicals, Inc. · Chemistry
Feb 1983
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K830238 is an FDA 510(k) clearance for the ULTRA CHEM CRESOLCAVERSACHEM #65082, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1983, 24 days after receiving the submission on January 25, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K830238 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1983
Decision Date February 18, 1983
Days to Decision 24 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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