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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Types, H. Influenza
510(k) Number K820192
Device Name HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM
Applicant
Hyland Therapeutic Div., Travenol Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hyland Therapeutic Div., Travenol Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3300
Classification Product Code
GRP  
Date Received01/25/1982
Decision Date 03/11/1982
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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