BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY— 510(k) K933589

Name: FDA 510(k) clearance K933589
Creator: U.S. Food and Drug Administration
Published: 1993-11-03

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K933589 for BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY, Substantially Equivalent on 1993-11-03. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 1993-07-26
Decision date: 1993-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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