Ames Tda Primidone Test
FDA 510(k) K802654 · Miles Laboratories, Inc.
510(k) numberK802654
Submission
- Device name
- Ames Tda Primidone Test
- Applicant
- Miles Laboratories, Inc.
Walker, MI, US - Received
- October 24, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJD – Enzyme Immunoassay, Primidone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3680
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973582 | Ace Primidone Reagent, AED CalibratorsDJD · Traditional | Schiapparelli Biosystems, Inc. | 11/12/1997SE |
| K910527 | Emit Convenience Pack for the Cobas Mira PrimidoneDJD · Traditional | Syva Co. | 03/14/1991SE |
| K840939 | Emit QST Primidone AssayDJD · Traditional | Syva Co. | 04/24/1984SE |
| K832798 | Modifica-Of Emit AED Primidone AssayDJD · Traditional | Syva Co. | 10/14/1983SE |
| K820138 | Primidone Reagent Test KitDJD · Traditional | Beckman Instruments, Inc. | 01/28/1982SE |
| K813597 | TDX PrimidoneDJD · Traditional | Abbott Laboratories | 01/22/1982SE |
| K781957 | Analytical Test Pack, PrimidoneDJD · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/10/1979SE |
More from E.I. Dupont DE Nemours & Co., Inc.
| 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 Primidone Test cleared by the FDA?
Ames Tda Primidone Test (K802654) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 19 days after the submission was received.
What is the product code of K802654?
The FDA product code is DJD – Enzyme Immunoassay, Primidone, a Class II (moderate risk) device regulated under 21 CFR 862.3680.