Ames Tda Netilmicin Test & Serum
FDA 510(k) K832088 · Miles Laboratories, Inc.
510(k) numberK832088
Submission
- Device name
- Ames Tda Netilmicin Test & Serum
- Applicant
- Miles Laboratories, Inc.
Walker, MI, US - Received
- June 28, 1983
- Decision date
- October 28, 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 |
|---|---|---|---|
| K833715 | Emit Netilmicin AssayLCE · Traditional | Syva Co. | 12/27/1983SE |
| 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 |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Ames Tda Netilmicin Test & Serum cleared by the FDA?
Ames Tda Netilmicin Test & Serum (K832088) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 122 days after the submission was received.
What is the product code of K832088?
The FDA product code is LCE – Radioimmunoassay, Netilmicin (I-125), a Class II (moderate risk) device regulated under 21 CFR 862.3450.