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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, Chlamydia Spp.
510(k) Number K883776
Device Name BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE
Applicant
Btc Corp.
324 Campus Lane, Suite T
Suisun,  CA  94585
Applicant Contact JUNE POHLMAN
Correspondent
Btc Corp.
324 Campus Lane, Suite T
Suisun,  CA  94585
Correspondent Contact JUNE POHLMAN
Regulation Number866.3120
Classification Product Code
LKI  
Date Received09/06/1988
Decision Date 02/03/1989
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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