TOTAL BILIRUBIN REAGENT SET— 510(k) K040391

Name: FDA 510(k) clearance K040391
Creator: U.S. Food and Drug Administration
Published: 2004-06-02

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K040391 for TOTAL BILIRUBIN REAGENT SET, Substantially Equivalent on 2004-06-02. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2004-02-17
Decision date: 2004-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Pointe Scientific, Inc.,

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K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

Recalls naming K040391

K-number listed on FDA's recall record

Z-2586-2017 — Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.Class II·Terminated·Medtest Holdings, Inc.·20120313

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040391.

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