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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 Immunosorbent Assay, T. Cruzi
510(k) Number K933716
Device Name ABBOTT CHAGAS ANTIBODY EIA
Applicant
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Applicant Contact MARY SPIEWAK
Correspondent
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent Contact MARY SPIEWAK
Regulation Number866.3870
Classification Product Code
MIU  
Date Received07/30/1993
Decision Date 12/19/1994
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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