Cleared Traditional

ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)

K883387 · Tech-Co, Inc. · Chemistry
Oct 1988
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K883387 is an FDA 510(k) clearance for the ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD), a Hydrazone Colorimetry, Alt/sgpt (Class I — General Controls, product code CKD), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on October 13, 1988, 64 days after receiving the submission on August 10, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K883387 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1988
Decision Date October 13, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKD — Hydrazone Colorimetry, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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