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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Russel Viper Venom
510(k) Number K990580
Device Name CRYOCHECK LA SURE, MODEL SUR25-10
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 Number864.8950
Classification Product Code
GIR  
Date Received02/23/1999
Decision Date 07/28/1999
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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