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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K850217
Device Name CYNOMOLGUS MONKEY BLOOD IN ALSEVER'S
Applicant
Hazleton Research Products, Inc.
Box 7200
Denver,  PA  17517
Applicant Contact JAMES K NOEL
Correspondent
Hazleton Research Products, Inc.
Box 7200
Denver,  PA  17517
Correspondent Contact JAMES K NOEL
Regulation Number864.2220
Classification Product Code
KIT  
Date Received01/22/1985
Decision Date 03/07/1985
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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