Cleared Traditional

CA BUFFER CA DYE

K852002 · Alpkem Corp. · Chemistry
Jun 1985
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K852002 is an FDA 510(k) clearance for the CA BUFFER CA DYE, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on June 25, 1985, 49 days after receiving the submission on May 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K852002 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1985
Decision Date June 25, 1985
Days to Decision 49 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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