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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, (Chlamydiae Group)
510(k) Number K862948
Device Name CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)
Applicant
Intercare Diagnostics, Inc.
1440 4th St.
Berkeley,  CA  94710
Applicant Contact STAN TSING
Correspondent
Intercare Diagnostics, Inc.
1440 4th St.
Berkeley,  CA  94710
Correspondent Contact STAN TSING
Regulation Number866.3120
Classification Product Code
LJC  
Date Received08/05/1986
Decision Date 10/17/1986
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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