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FDA 510(k), K061328, THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
FDA 510(k), K061328, THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
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510(K) Number: K061328
Device Name: THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
Manufacturer: E-SAN LIMITED
Device Classification Name: system, test, blood glucose, over the counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 05/12/2006
Decision Date: 06/13/2006
Regulation Medical Specialty: Clinical Chemistry
Device Name: THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
Manufacturer: E-SAN LIMITED
Device Classification Name: system, test, blood glucose, over the counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 05/12/2006
Decision Date: 06/13/2006
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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