FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KEITHLEY LYMPHOCYTE DEPLETION CART
K Number: K801899
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
2
Review Days
49
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Basic Information
- Device Name
- KEITHLEY LYMPHOCYTE DEPLETION CART
- K Number
- K801899
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Keithley Development Co.
- Date Received
- August 8, 1980
- Decision Date
- September 26, 1980
- Product Code
- KDK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDK | Container, Transport, Kidney | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Keithley Development Co.
| K Number | Device Name | ||
|---|---|---|---|
| K792256 | KEITHLEY CLAMP | Dec 6, 1979 | Substantially Equivalent |