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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Adenovirus 1-33
510(k) Number K881894
Device Name ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
Applicant
Cambridge Bioscience Corp.
365 Plantation St.
Worcester,  MA  01605
Applicant Contact JACK CASSORLA
Correspondent
Cambridge Bioscience Corp.
365 Plantation St.
Worcester,  MA  01605
Correspondent Contact JACK CASSORLA
Regulation Number866.3020
Classification Product Code
GOD  
Date Received05/05/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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