Cleared Traditional

AMMONIA ASSAY CAT. NO. 200-02

K932556 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry
Aug 1994
Decision
433d
Days
Class 1
Risk

About This 510(k) Submission

K932556 is an FDA 510(k) clearance for the AMMONIA ASSAY CAT. NO. 200-02, a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on August 2, 1994, 433 days after receiving the submission on May 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K932556 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 1993
Decision Date August 02, 1994
Days to Decision 433 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIF — Enzymatic Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065

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