510(k) K822808
- Device
- Tdx Kenamycin
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K822808
- Product code
- KJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-10-08
- Date received
- 1982-09-17
- Regulation
- 862.3520
- Classification name
- Radioimmunoassay, Kanamycin
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KJI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832769 | AMES TDA KANAMYCIN TEST-CONTROL SERUM | Miles Laboratories, Inc. | 1983-09-29 |
| K823370 | ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY | Syva Co. | 1982-12-03 |
| K823062 | KENAMYCIN FLUORESCENT IMMUNOASSAY FIA | American Diagnostic Corp. | 1982-11-10 |
| K782125 | RIA KIT, KANAMYCIN | Diagnostic Products Corp. | 1979-01-10 |
| K772038 | KANAMYCIN RIA | Monitor Science Corp. | 1978-01-12 |