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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 K183440
Device Name CRYOcheck FVIII Inhibitor Kit
Applicant
Precision Biologic, Inc.
140 Eileen Stubbs Ave.
Darmouth,  CA B3B 0A9
Applicant Contact Karen M. Black
Correspondent
Precision Biologic, Inc.
140 Eileen Stubbs Ave.
Darmouth,  CA B3B 0A9
Correspondent Contact Karen M. Black
Regulation Number864.7290
Classification Product Code
GGP  
Subsequent Product Code
GGN  
Date Received12/12/2018
Decision Date 03/12/2019
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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