POINTE 750 GLYCOMETER
FDA 510(k) clearance K920449 · decided 1992-07-28
Clearance details
- K-number
- K920449
- Device name
- POINTE 750 GLYCOMETER
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1992-02-02
- Decision date
- 1992-07-28
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lincoln Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.