QUANTIMETRIX BILIRUBIN CALIBRATORS— 510(k) K895778

Name: FDA 510(k) clearance K895778
Creator: U.S. Food and Drug Administration
Published: 1989-11-14

Substantially Equivalent

Quantimetrix Medical Industries

FDA 510(k) clearance K895778 for QUANTIMETRIX BILIRUBIN CALIBRATORS, Substantially Equivalent on 1989-11-14. Applicant: Quantimetrix Medical Industries. Device class: 2.

Clearance details

Applicant: Quantimetrix Medical Industries
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1989-09-27
Decision date: 1989-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hawthorne, CA, US

Download summary PDF View on FDA.gov ↗

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