URIC ACID REAGENT SET (COLORIMETRIC)— 510(k) K860142

Name: FDA 510(k) clearance K860142
Creator: U.S. Food and Drug Administration
Published: 1986-02-11

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860142 for URIC ACID REAGENT SET (COLORIMETRIC), Substantially Equivalent on 1986-02-11. Applicant: Sterling Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code LFQ
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1986-01-14
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFQ

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K860111 — URIC ACID REAGENT SET1986-02-19
K844075 — URIC ACID REAGENT SET1984-10-30
K812313 — SANDARE URIC ACID PROCEDURE1981-09-01
K811764 — URIC ACID REAGENT SET1981-08-20

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 K860142

K-number listed on FDA's recall record

Z-0937-2017 — Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) 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 K860142.

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