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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, Toxoplasma Gondii
510(k) Number K001707
Device Name DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
Applicant
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Applicant Contact LYNNE STIRLING
Correspondent
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Correspondent Contact LYNNE STIRLING
Regulation Number866.3780
Classification Product Code
LGD  
Date Received06/05/2000
Decision Date 07/07/2000
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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