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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Factor Deficient
510(k) Number K990296
Device Name CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
Applicant
Precision Biologic
900 Windmill Rd., Suite 100
Dartmouth, N.S.,  CA B3B 1P7
Applicant Contact SANDY MORRISON
Correspondent
Precision Biologic
900 Windmill Rd., Suite 100
Dartmouth, N.S.,  CA B3B 1P7
Correspondent Contact SANDY MORRISON
Regulation Number864.7290
Classification Product Code
GJT  
Date Received01/28/1999
Decision Date 03/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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