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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K952624
Device Name CRYO CHECK ABNORMAL REFERENCE CHECK I & II
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
GGC  
Subsequent 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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