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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Parainfluenza Virus 1-4
510(k) Number K780008
Device Name GOAT ANTI-INFLUENZA ANTISERA
Applicant
Northeast Biomedical Labs., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Northeast Biomedical Labs., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3400
Classification Product Code
GQT  
Date Received01/03/1978
Decision Date 01/20/1978
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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