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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Control), Cytomegalovirus
510(k) Number K882835
Device Name INDIRECT FLUORESCENT ASSAY FOR (HCMV)
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 Number866.3175
Classification Product Code
GQH  
Date Received07/08/1988
Decision Date 12/05/1988
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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