Cleared Traditional

EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405

K893692 · Diagnostic Systems · Chemistry
Aug 1989
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K893692 is an FDA 510(k) clearance for the EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on August 21, 1989, 97 days after receiving the submission on May 16, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K893692 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1989
Decision Date August 21, 1989
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIT — Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100

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