Data / Medical devices / United States / Rosie Connectivity Solutions, Inc.
Rosie Connectivity Solutions, Inc.: FDA-registered device maker in Savannah, GA, United States, 1 510(k) clearance
Rosie Connectivity Solutions, Inc. is registered with the FDA (registration 3005393828) in Savannah, GA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005393828
- Address
- 7320 Central Ave, Savannah, GA, United States, 31406
- Owner or operator
- Rosie Connectivity Solutions, Inc. (10062214)
- Roles
- Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 26, 2026
- Registered through
- 2026
- Brand names listed
- Rosie RealTime Blood Glucose Monitoring System, Rosie RealTime Blood Glucose Teset Strips (50/box), Rosie RealTime Blood Glucose Test_Strips Foil Wrap, Rosie RealTime Glucose Control Solution Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 28, 2010 | K100322 | TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated June 28, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.