510(k) K833715
- Device
- Emit Netilmicin Assay
- Applicant
- SYVA CO.
- 510(k) number
- K833715
- Product code
- LCE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-12-27
- Date received
- 1983-10-21
- Regulation
- 862.3450
- Classification name
- Radioimmunoassay, Netilmicin (I-125)
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- 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 LCE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832088 | AMES TDA NETILMICIN TEST & SERUM | Miles Laboratories, Inc. | 1983-10-28 |
| K822941 | NETILMICIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-10-26 |
| K821698 | TDX NETILMICIN | Abbott Laboratories | 1982-06-22 |
| K821399 | MACRO-VUE CARD TEST, NETILMICIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-05-28 |
| K820324 | EMIT AND NETILMICIN ASSAY | Syva Co. | 1982-02-23 |