Ames Tda Gentamicin Test
FDA 510(k) K821669 · Miles Laboratories, Inc.
510(k) numberK821669
Submission
- Device name
- Ames Tda Gentamicin Test
- Applicant
- Miles Laboratories, Inc.
Walker, MI, US - Received
- June 7, 1982
- Decision date
- December 15, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJB – Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832792 | Ames Tda Sisomicin Test-Control SerumDJB · Traditional | Miles Laboratories, Inc. | 09/29/1983SE |
| K831210 | Gentamicin Test Pack-AcaDJB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 05/25/1983SE |
| K812394 | MRI Gentamicin Ria KitDJB · Traditional | Microanalytic Research, Inc. | 09/08/1981SE |
| K811844 | Coat-A-Count Gentamicin Ria KitDJB · Traditional | Diagnostic Products Corp. | 07/10/1981SE |
| K800537 | Gamma Stick Gentamicin Ria KitDJB · Traditional | Alpha Gamma Laboratory | 04/24/1980SE |
| K791770 | Quantimune Gentamicin Ria GentamicinDJB · Traditional | Bio-Rad | 10/17/1979SE |
| K791547 | Fluoromatic Gentamicin Fia ImmunoassayDJB · Traditional | Bio-Rad | 10/12/1979SE |
| K782049 | Bioassay System, MS-2 SerumDJB · Traditional | Abbott Laboratories | 08/28/1979SE |
| K790584 | Ames Tda/GentgmicinDJB · Traditional | Miles Laboratories, Inc. | 06/15/1979SE |
| K790829 | Emit Gentamicin AssayDJB · Traditional | Syva Co. | 05/15/1979SE |
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| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
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| 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 Gentamicin Test cleared by the FDA?
Ames Tda Gentamicin Test (K821669) received a 510(k) decision of Substantially Equivalent on December 15, 1982, 191 days after the submission was received.
What is the product code of K821669?
The FDA product code is DJB – Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3450.