Primidone Reagent Test Kit
FDA 510(k) K820138 · Beckman Instruments, Inc.
510(k) numberK820138
Submission
- Device name
- Primidone Reagent Test Kit
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- January 18, 1982
- Decision date
- January 28, 1982
- 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 |
| K813597 | TDX PrimidoneDJD · Traditional | Abbott Laboratories | 01/22/1982SE |
| K802654 | Ames Tda Primidone TestDJD · Traditional | Miles Laboratories, Inc. | 11/12/1980SE |
| 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 |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Primidone Reagent Test Kit cleared by the FDA?
Primidone Reagent Test Kit (K820138) received a 510(k) decision of Substantially Equivalent on January 28, 1982, 10 days after the submission was received.
What is the product code of K820138?
The FDA product code is DJD – Enzyme Immunoassay, Primidone, a Class II (moderate risk) device regulated under 21 CFR 862.3680.