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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sera, Animal And Human
510(k) Number K881287
Device Name ANIMAL AND HUMAN SERA
Applicant
Cell Culture Laboratories
4400 Emery Industrial Pkwy.
Cleveland,  OH  44128
Applicant Contact CHARLES D CLARK
Correspondent
Cell Culture Laboratories
4400 Emery Industrial Pkwy.
Cleveland,  OH  44128
Correspondent Contact CHARLES D CLARK
Regulation Number864.2800
Classification Product Code
KIS  
Date Received03/28/1988
Decision Date 04/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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