ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
FDA 510(k) clearance K041881 · decided 2005-03-25
Clearance details
- K-number
- K041881
- Device name
- ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
- Applicant
- Hypoguard USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-12
- Decision date
- 2005-03-25
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Edina, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.