TINA-QUANT HAPTOGLOBIN— 510(k) K972639

Name: FDA 510(k) clearance K972639
Creator: U.S. Food and Drug Administration
Published: 1998-01-09

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K972639 for TINA-QUANT HAPTOGLOBIN, Substantially Equivalent on 1998-01-09. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DAD
Device class: Class 2
Regulation: 21 CFR 866.5460
Advisory panel: Immunology
Date received: 1997-07-15
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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