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FDA 510(k), K894293, MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
FDA 510(k), K894293, MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
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510(K) Number: K894293
Device Name: MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
Manufacturer: MARDX DIAGNOSTICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 06/23/1989
Decision Date: 08/21/1989
Regulation Medical Specialty: Microbiology
Device Name: MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
Manufacturer: MARDX DIAGNOSTICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 06/23/1989
Decision Date: 08/21/1989
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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