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Substantially Equivalent 510(k) Device Information
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Resources for You
Cleared 510(k) Submissions with Supporting Documents
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Platelet PGD Test System
Applicant:
Verax Biomedical Incorporated
510(k) number:
BK070044
Product:
Platelet PGD Test System
Date:
09/17/2007
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Supporting Documents
BK070044 Letter
BK070044 Summary
(PDF - 280KB)
BK070044 Package Insert
(PDF - 270KB)
FDA Clears for Marketing First Rapid Test to Screen for Bacterial Contamination in Blood Platelets
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