CD8 CYTOSPHERES KIT
FDA 510(k) clearance K923951 · decided 1994-04-25
Clearance details
- K-number
- K923951
- Device name
- CD8 CYTOSPHERES KIT
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-06
- Decision date
- 1994-04-25
- Days to decision
- 627 days
- Clearance type
- Traditional
- Product code
- MAM
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hialeah, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.