INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
FDA 510(k) clearance K040146 · decided 2004-05-04
Clearance details
- K-number
- K040146
- Device name
- INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- Applicant
- Interlab S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-22
- Decision date
- 2004-05-04
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- GKA
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- East Stroudsburg, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.