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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K193204
Device Name Cryocheck Chromogenic Factor VIII
Applicant
Precision Biologic
140 Eileen Stubbs Ave.
Darmouth,  CA B3B 0A9
Applicant Contact Karen Black
Correspondent
Precision Biologic
140 Eileen Stubbs Ave.
Darmouth,  CA B3B 0A9
Correspondent Contact Karen Black
Regulation Number864.7290
Classification Product Code
GGP  
Date Received11/20/2019
Decision Date 07/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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