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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, All Types, Hemophilus Spp.
510(k) Number K802423
Device Name PHADEBACT HAEMOPHILUS TEST
Applicant
Pharmacia, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pharmacia, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3300
Classification Product Code
GRO  
Date Received10/03/1980
Decision Date 11/12/1980
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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