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FDA 510(k), K151658, Gmate Origin Blood Glucose Monitoring System
FDA 510(k), K151658, Gmate Origin Blood Glucose Monitoring System
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510(K) Number: K151658
Device Name: Gmate Origin Blood Glucose Monitoring System
Manufacturer: LINDA CHAN
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: KXA
Date Received: 06/19/2015
Decision Date: 12/01/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: Gmate Origin Blood Glucose Monitoring System
Manufacturer: LINDA CHAN
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: KXA
Date Received: 06/19/2015
Decision Date: 12/01/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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