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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K193556
Device Name Cryocheck Hex LA
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 Number864.7925
Classification Product Code
GFO  
Date Received12/23/2019
Decision Date 10/23/2020
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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