FDA 510(k), K151658, Gmate Origin Blood Glucose Monitoring System
FDA 510(k), K151658, Gmate Origin Blood Glucose Monitoring System
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
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: 06/19/2015
Date Received: 12/01/2015
Decision Date: 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: 06/19/2015
Date Received: 12/01/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
- 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.
View full details