CREATININE REAGENT SET— 510(k) K860418

Name: FDA 510(k) clearance K860418
Creator: U.S. Food and Drug Administration
Published: 1986-02-11

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860418 for CREATININE REAGENT SET, Substantially Equivalent on 1986-02-11. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1986-02-04
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sterling Diagnostics, Inc.

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K921412 — MICROPROTEIN REAGENT SET1993-01-21
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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 K860418

K-number listed on FDA's recall record

Z-0931-2017 — Creatinine/Endpoint [Modified Heinegard-Tiderstrom] 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 K860418.

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