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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 K935807
Device Name ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
Applicant
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact CAROLE STAMP
Correspondent
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact CAROLE STAMP
Regulation Number866.3120
Classification Product Code
LJC  
Date Received12/02/1993
Decision Date 05/19/1995
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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