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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K853069
Device Name TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
Applicant
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Applicant Contact JOHN F BRUNI
Correspondent
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Correspondent Contact JOHN F BRUNI
Regulation Number866.3510
Classification Product Code
LFX  
Date Received07/22/1985
Decision Date 01/01/1986
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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