Primidone (Fpia) Kit
FDA 510(k) K895567 · Tudor Laboratories, Inc.
510(k) numberK895567
Submission
- Device name
- Primidone (Fpia) Kit
- Applicant
- Tudor Laboratories, Inc.
Dallas, TX, US - Received
- September 6, 1989
- Decision date
- October 20, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFT – Fluorescent Immunoassay, Primidone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3680
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950028 | Primidone Fpia Reagent Set and CalibratorsLFT · Traditional | Sigma Diagnostics, Inc. | 03/21/1995SE |
| K904683 | Stratus Primidone Fluorometric EnzymeLFT · Traditional | Baxter Healthcare Corp | 11/28/1990SE |
| K852318 | Cobas FP Reagen for Primidone & Primi CalibratorsLFT · Traditional | Roche Diagnostic Systems, Inc. | 06/25/1985SE |
| K842196 | Stratus Primidone Florometric EnzyLFT · Traditional | American Dade | 07/11/1984SE |
| K823741 | Advance Emit-Aed Primedone AssayLFT · Traditional | Syva Co. | 01/07/1983SE |
| K822229 | Primidone Fluorescent ImmunoassayLFT · Traditional | American Diagnostic Corp. | 08/12/1982SE |
| K811007 | Ames Tda TM Primidone TestLFT · Traditional | Miles Laboratories, Inc. | 04/29/1981SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921904 | Thyroxine (Fpia) KitKLI · Traditional | 06/24/1992SE |
| K921903 | Thyroxine Calibrator KitJIS · Traditional | 05/26/1992SE |
| K913240 | Digitoxin (Fpia) KitLFM · Traditional | 09/06/1991SE |
| K895572 | N-Acetylprocainamide (Napa) Calibrator KitDLJ · Traditional | 10/30/1989SE |
| K895571 | N-Acetylprocainamide (Napa) (Fpia) KitLAN · Traditional | 10/25/1989SE |
| K895569 | Valproic Acid (Fpia) KitLEG · Traditional | 10/03/1989SE |
| K895570 | Valproic Acid (Fpia) Calibrator KitDLJ · Traditional | 09/28/1989SE |
| K895568 | Primidone (Fpia) Calibrator KitDLJ · Traditional | 09/28/1989SE |
Questions and answers
When was Primidone (Fpia) Kit cleared by the FDA?
Primidone (Fpia) Kit (K895567) received a 510(k) decision of Substantially Equivalent on October 20, 1989, 44 days after the submission was received.
What is the product code of K895567?
The FDA product code is LFT – Fluorescent Immunoassay, Primidone, a Class II (moderate risk) device regulated under 21 CFR 862.3680.