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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 Control
510(k) Number K952622
Device Name CRYO CHECK NORMAL HUMAN REFERENCE PLASMA
Applicant
Precision Biologicals, Inc.
900 Windmill Rd.
Unit 100
Dartmouth, Nova Scotia,  CA B3B 1P7
Applicant Contact STEPHEN L DUFF
Correspondent
Precision Biologicals, Inc.
900 Windmill Rd.
Unit 100
Dartmouth, Nova Scotia,  CA B3B 1P7
Correspondent Contact STEPHEN L DUFF
Regulation Number864.5425
Classification Product Code
GGN  
Date Received06/08/1995
Decision Date 10/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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