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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K880144
Device Name STANBIO SYPHILIS RPR TEST, NO. 1170
Applicant
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Applicant Contact WILLIAM CAMPBELL,PHD
Correspondent
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Correspondent Contact WILLIAM CAMPBELL,PHD
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received01/13/1988
Decision Date 05/23/1988
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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