CD4 CYTOSPHERES KIT
FDA 510(k) clearance K921279 · decided 1992-12-29
Clearance details
- K-number
- K921279
- Device name
- CD4 CYTOSPHERES KIT
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-17
- Decision date
- 1992-12-29
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hialeah, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coulter Electronics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.