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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 K902253
Device Name PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
Applicant
Kallestad Diag, A Div. of Erbamont, Inc.
2000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact CHERI W FINK
Correspondent
Kallestad Diag, A Div. of Erbamont, Inc.
2000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact CHERI W FINK
Regulation Number866.3120
Classification Product Code
LJC  
Date Received05/21/1990
Decision Date 07/26/1990
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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