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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 K884517
Device Name PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
Applicant
Kallestad Diag, A Div. of Erbamont, Inc.
2000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact QUINLAN SMITH
Correspondent
Kallestad Diag, A Div. of Erbamont, Inc.
2000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact QUINLAN SMITH
Regulation Number866.3120
Classification Product Code
LJC  
Date Received10/27/1988
Decision Date 11/30/1988
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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