GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k) clearance K121433 · decided 2013-02-14
Clearance details
- K-number
- K121433
- Device name
- GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
- Applicant
- Hmd Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-14
- Decision date
- 2013-02-14
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- LFR
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Xinpu Township, Hsinchu County, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.