FDA 510(k) Application Details - K001707

Device Classification Name Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

  More FDA Info for this Device
510(K) Number K001707
Device Name Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI, FL 33127 US
Other 510(k) Applications for this Company
Contact LYNNE STIRLING
Other 510(k) Applications for this Contact
Regulation Number 866.3780

  More FDA Info for this Regulation Number
Classification Product Code LGD
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/05/2000
Decision Date 07/07/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact