Digitoxin (Fpia) Kit
FDA 510(k) K913240 · Tudor Laboratories, Inc.
510(k) numberK913240
Submission
- Device name
- Digitoxin (Fpia) Kit
- Applicant
- Tudor Laboratories, Inc.
Dallas, TX, US - Received
- July 22, 1991
- Decision date
- September 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFM – Enzyme Immunoassay, Digitoxin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3300
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062024 | Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…LFM · Special | Dade Behring, Inc. | 07/28/2006SE |
| K012112 | Randox DigitoxinLFM · Traditional | Randox Laboratories, Ltd. | 01/11/2002SE |
| K990251 | DGTX Flex Reagent Cartridge, Model DF36LFM · Traditional | Dade Behring, Inc. | 03/31/1999SE |
| K970546 | Acs DigitoxinLFM · Traditional | Chiron Diagnostics Corp. | 07/14/1997SE |
| K963158 | Abbott Axsym Digitoxin (Modify)LFM · Traditional | Abbott Laboratories | 09/10/1996SE |
| K954420 | Axsym DigitoxinLFM · Traditional | Abbott Laboratories | 12/29/1995SE |
| K951631 | Digoxin Assay for the Tecchnicon Ra/Opera Systems In-Vitro Diagnostic SystemsLFM · Traditional | Bayer Corp. | 06/09/1995SE |
| K943235 | Immulite DigitoxinLFM · Traditional | Diagnostic Products Corp. | 10/27/1994SE |
| K942610 | Kodak Extachem Clinical Chemistry Slide Digoxin (DGXN)LFM · Traditional | Eastman Kodak Company | 10/20/1994SE |
| K942619 | Emit 2000 Digoxin Assay/CalibratorsLFM · Traditional | Syva Co. | 09/20/1994SE |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K921904 | Thyroxine (Fpia) KitKLI · Traditional | 06/24/1992SE |
| K921903 | Thyroxine Calibrator KitJIS · Traditional | 05/26/1992SE |
| K895572 | N-Acetylprocainamide (Napa) Calibrator KitDLJ · Traditional | 10/30/1989SE |
| K895571 | N-Acetylprocainamide (Napa) (Fpia) KitLAN · Traditional | 10/25/1989SE |
| K895567 | Primidone (Fpia) KitLFT · Traditional | 10/20/1989SE |
| 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 Digitoxin (Fpia) Kit cleared by the FDA?
Digitoxin (Fpia) Kit (K913240) received a 510(k) decision of Substantially Equivalent on September 6, 1991, 46 days after the submission was received.
What is the product code of K913240?
The FDA product code is LFM – Enzyme Immunoassay, Digitoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3300.