BUN (ENZYMATIC BERTHELOT) REAGENT SET— 510(k) K860154

Name: FDA 510(k) clearance K860154
Creator: U.S. Food and Drug Administration
Published: 1986-02-06

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860154 for BUN (ENZYMATIC BERTHELOT) REAGENT SET, Substantially Equivalent on 1986-02-06. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CDL
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1986-01-16
Decision date: 1986-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

Download summary PDF View on FDA.gov ↗

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K871651 — COLORIMETRIC BUN REAGENT KIT1987-05-12
K864742 — UREA NITROGEN(BUN), COLORIMETRIC METHOD1987-01-13
K863889 — UREA NITROGEN TEST1986-11-24

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 K860154

K-number listed on FDA's recall record

Z-0936-2017 — Urea Nitrogen/Color BUN (Enzymatic Berthelot) 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 K860154.

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