ELECSYS T4 ASSAY— 510(k) K961490

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K961490 for ELECSYS T4 ASSAY, Substantially Equivalent on 1996-06-13. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CDX
Advisory panel: Clinical Chemistry
Date received: 1996-04-18
Decision date: 1996-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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