SGOT (AST) REAGENT SET— 510(k) K860216

Name: FDA 510(k) clearance K860216
Creator: U.S. Food and Drug Administration
Published: 1986-04-03

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860216 for SGOT (AST) REAGENT SET, Substantially Equivalent on 1986-04-03. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CIQ
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Date received: 1986-01-22
Decision date: 1986-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

Download summary PDF View on FDA.gov ↗

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K844322 — SGOT REAGENT SET1984-11-27
K841065 — SGOT REAGENT SET1984-05-01
K821209 — SGOT REAGENT SET1982-07-14

More clearances from Sterling Diagnostics, Inc.

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K921412 — MICROPROTEIN REAGENT SET1993-01-21
K914609 — TRIGLYCERIDES REAGENT SET1991-11-07
K914039 — SODIUM REAGENT SET1991-10-31
K914040 — PHOSPHOLIPID REAGENT SET1991-10-30
K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)1986-07-29

Recalls naming K860216

K-number listed on FDA's recall record

Z-0934-2017 — Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.Class III·Terminated·Sterling Diagnostics, Inc.·20160720

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K860216.

Data sourced from openFDA. This site is unofficial and independent of the FDA.