QUANTIMETRIX BROMERESOL PURPLE ALBUMIN— 510(k) K830934

Name: FDA 510(k) clearance K830934
Creator: U.S. Food and Drug Administration
Published: 1983-04-18

Substantially Equivalent

Quantimetrix Corp.

FDA 510(k) clearance K830934 for QUANTIMETRIX BROMERESOL PURPLE ALBUMIN, Substantially Equivalent on 1983-04-18. Applicant: Quantimetrix Corp.. Device class: 2.

Clearance details

Applicant: Quantimetrix Corp.
Product code: Code CJW
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1983-03-23
Decision date: 1983-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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