DIAZO COLORIMETRY, BILIRUBIN— 510(k) K914873

Name: FDA 510(k) clearance K914873
Creator: U.S. Food and Drug Administration
Published: 1991-12-04

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K914873 for DIAZO COLORIMETRY, BILIRUBIN, Substantially Equivalent on 1991-12-04. 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: 1991-10-29
Decision date: 1991-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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