Cleared Traditional

SGPT REAGENT SET

K844283 · Livonia Diagnostics, Inc. · Chemistry
Nov 1984
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K844283 is an FDA 510(k) clearance for the SGPT REAGENT SET, a Hydrazone Colorimetry, Alt/sgpt (Class I — General Controls, product code CKD), submitted by Livonia Diagnostics, Inc. (Livonia, US). The FDA issued a Cleared decision on November 27, 1984, 22 days after receiving the submission on November 5, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K844283 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1984
Decision Date November 27, 1984
Days to Decision 22 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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