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FDA 510(k), K993319, VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
FDA 510(k), K993319, VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
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510(K) Number: K993319
Device Name: VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
Manufacturer: ANNA DEMARINIS
Device Classification Name: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Regulation Number: LGD
Classification Product Code: 10/04/1999
Date Received: 05/22/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
Manufacturer: ANNA DEMARINIS
Device Classification Name: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Regulation Number: LGD
Classification Product Code: 10/04/1999
Date Received: 05/22/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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