MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
FDA 510(k) clearance K011233 · decided 2001-05-18
Clearance details
- K-number
- K011233
- Device name
- MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
- Applicant
- Apex BioTechnology Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-23
- Decision date
- 2001-05-18
- Days to decision
- 25 days
- Clearance type
- Special
- 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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|---|---|---|
| Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, C recall (Z-0699-2008) | ARKRAY USA INC. | 2008-02-01 |