HEMA SCREEN ER
FDA 510(k) clearance K102664 · decided 2011-01-28
Clearance details
- K-number
- K102664
- Device name
- HEMA SCREEN ER
- Applicant
- Immunostics Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2010-09-15
- Decision date
- 2011-01-28
- Days to decision
- 135 days
- Clearance type
- Special
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Ocean, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.