Abbott Axsym Digitoxin (Modify)
FDA 510(k) K963158 · Abbott Laboratories
510(k) numberK963158
Submission
- Device name
- Abbott Axsym Digitoxin (Modify)
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 26, 1996
- Decision date
- September 10, 1996
- 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
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| 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 |
| 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 |
| K915465 | Digitoxin Fpia Reagent SetLFM · Traditional | Sigma Diagnostics, Inc. | 01/27/1992SE |
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Questions and answers
When was Abbott Axsym Digitoxin (Modify) cleared by the FDA?
Abbott Axsym Digitoxin (Modify) (K963158) received a 510(k) decision of Substantially Equivalent on September 10, 1996, 46 days after the submission was received.
What is the product code of K963158?
The FDA product code is LFM – Enzyme Immunoassay, Digitoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3300.