SYMCARE DIABETES MANAGEMENT PROGRAM
FDA 510(k) clearance K083263 · decided 2009-03-13
Clearance details
- K-number
- K083263
- Device name
- SYMCARE DIABETES MANAGEMENT PROGRAM
- Applicant
- Symcare Personalized Health Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-05
- Decision date
- 2009-03-13
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.