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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
510(k) Number K921075
Device Name PHADEBACT MONOCLONAL GC TEST, MODIFICATION
Applicant
Karo Bio Diagnostics AB
Lunastigen 3
S-141 44 Huddinge, Sweden,  SC
Applicant Contact BENGT GUSTAVSSON
Correspondent
Karo Bio Diagnostics AB
Lunastigen 3
S-141 44 Huddinge, Sweden,  SC
Correspondent Contact BENGT GUSTAVSSON
Regulation Number866.3390
Classification Product Code
LIC  
Date Received02/28/1992
Decision Date 05/22/1992
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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