510(k) K832769
- Device
- AMES TDA KANAMYCIN TEST-CONTROL SERUM
- Applicant
- MILES LABORATORIES, INC.
- 510(k) number
- K832769
- Product code
- KJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-29
- Date received
- 1983-08-16
- Regulation
- 862.3520
- Classification name
- Radioimmunoassay, Kanamycin
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KJI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823370 | ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY | Syva Co. | 1982-12-03 |
| K823062 | KENAMYCIN FLUORESCENT IMMUNOASSAY FIA | American Diagnostic Corp. | 1982-11-10 |
| K822808 | TDX KENAMYCIN | Abbott Laboratories | 1982-10-08 |
| K782125 | RIA KIT, KANAMYCIN | Diagnostic Products Corp. | 1979-01-10 |
| K772038 | KANAMYCIN RIA | Monitor Science Corp. | 1978-01-12 |
Legacy Summary#
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FDA Review#
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