TINA-QUANT PREALBUMIN— 510(k) K972638

Name: FDA 510(k) clearance K972638
Creator: U.S. Food and Drug Administration
Published: 1998-01-09

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K972638 for TINA-QUANT PREALBUMIN, Substantially Equivalent on 1998-01-09. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
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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