Emit Netilmicin Assay
FDA 510(k) K833715 · Syva Co.
510(k) numberK833715
Submission
- Device name
- Emit Netilmicin Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- October 21, 1983
- Decision date
- December 27, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCE – Radioimmunoassay, Netilmicin (I-125)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LCE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832088 | Ames Tda Netilmicin Test & SerumLCE · Traditional | Miles Laboratories, Inc. | 10/28/1983SE |
| K822941 | Netilmicin Fluorescent ImmunoassayLCE · Traditional | American Diagnostic Corp. | 10/26/1982SE |
| K821698 | TDX NetilmicinLCE · Traditional | Abbott Laboratories | 06/22/1982SE |
| K821399 | Macro-Vue Card Test, NetilmicinLCE · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/28/1982SE |
| K820324 | Emit and Netilmicin AssayLCE · Traditional | Syva Co. | 02/23/1982SE |
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Questions and answers
When was Emit Netilmicin Assay cleared by the FDA?
Emit Netilmicin Assay (K833715) received a 510(k) decision of Substantially Equivalent on December 27, 1983, 67 days after the submission was received.
What is the product code of K833715?
The FDA product code is LCE – Radioimmunoassay, Netilmicin (I-125), a Class II (moderate risk) device regulated under 21 CFR 862.3450.