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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 K914953
Device Name IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
Applicant
Stellar Bio Systems, Inc.
9075 Guilford Rd.
Columbia,  MD  21046
Applicant Contact JOHN M.BREWER
Correspondent
Stellar Bio Systems, Inc.
9075 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact JOHN M.BREWER
Regulation Number866.3120
Classification Product Code
LKI  
Date Received11/05/1991
Decision Date 02/19/1992
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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