PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
FDA 510(k) clearance K100937 · decided 2010-12-21
Clearance details
- K-number
- K100937
- Device name
- PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
- Applicant
- I-Sens, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-05
- Decision date
- 2010-12-21
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.