Cleared Traditional

SGPT (ALT) REAGENT SET (COLORIMETRIC)

K860485 · Sterling Diagnostics, Inc. · Chemistry
Apr 1986
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K860485 is an FDA 510(k) clearance for the SGPT (ALT) REAGENT SET (COLORIMETRIC), a Hydrazone Colorimetry, Alt/sgpt (Class I — General Controls, product code CKD), submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on April 3, 1986, 52 days after receiving the submission on February 10, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K860485 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1986
Decision Date April 03, 1986
Days to Decision 52 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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