KEITHLEY LYMPHOCYTE DEPLETION CART
FDA 510(k) clearance K801899 · decided 1980-09-26
Clearance details
- K-number
- K801899
- Device name
- KEITHLEY LYMPHOCYTE DEPLETION CART
- Applicant
- Keithley Development Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-08
- Decision date
- 1980-09-26
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- KDK
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RM3 RENAL PRESERVATION SYSTEM (K053169) | Waters Instruments, Inc. | 2006-01-17 |
| HYPOTRANS MODEL 750 (K911577) | Martin Mclane Medical | 1992-07-08 |
Recalls involving this device
No recalls on record reference this clearance.