Cleared Traditional

HICHEM ISE DILUENT KIT 70008

K953860 · Hichem Diagnostics · Chemistry
Sep 1995
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K953860 is an FDA 510(k) clearance for the HICHEM ISE DILUENT KIT 70008, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on September 6, 1995, 20 days after receiving the submission on August 17, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K953860 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1995
Decision Date September 06, 1995
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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