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FDA 510(k), K033566, MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
FDA 510(k), K033566, MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
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510(K) Number: K033566
Device Name: MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
Manufacturer: RAPID DIAGNOSTICS, INC.
Device Classification Name: enzyme immunoassay, amphetamine
Regulation Number: 862.3100
Classification Product Code: DKZ
Date Received: 11/12/2003
Decision Date: 05/17/2004
Regulation Medical Specialty: Toxicology
Device Name: MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
Manufacturer: RAPID DIAGNOSTICS, INC.
Device Classification Name: enzyme immunoassay, amphetamine
Regulation Number: 862.3100
Classification Product Code: DKZ
Date Received: 11/12/2003
Decision Date: 05/17/2004
Regulation Medical Specialty: Toxicology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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