VISULIZE FACTOR IX ANTIGEN KIT— 510(k) K051054

Clearance details

Applicant

Affinity Biologicals, Inc.

Product code

Code GGP

Device class

Class 2

Regulation

21 CFR 864.7290

Advisory panel

Hematology

Date received

2005-04-26

Decision date

2005-06-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ancaster, Ontario, CA

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