Cleared Traditional

MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE

K875079 · Miles Laboratories, Inc. · Chemistry
Apr 1988
Decision
118d
Days
Class 1
Risk

About This 510(k) Submission

K875079 is an FDA 510(k) clearance for the MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on April 5, 1988, 118 days after receiving the submission on December 9, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K875079 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1987
Decision Date April 05, 1988
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKA — Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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