Cleared Traditional

HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808

K941764 · Hi Chem, Inc. · Chemistry
May 1994
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K941764 is an FDA 510(k) clearance for the HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on May 13, 1994, 45 days after receiving the submission on March 29, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K941764 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1994
Decision Date May 13, 1994
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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