TINTELIZER(R) TPA— 510(k) K934314

Substantially Equivalent

Biopool AB

FDA 510(k) clearance K934314 for TINTELIZER(R) TPA, Substantially Equivalent on 1994-02-23. Applicant: Biopool AB.

Clearance details

Applicant: Biopool AB
Product code: Code GGP
Advisory panel: Hematology
Date received: 1993-09-01
Decision date: 1994-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, L7l 6b8, CA

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