Sopheia/Mp Digitoxin Eia Kit
FDA 510(k) K842578 · Diagnostic Products Corp.
510(k) numberK842578
Submission
- Device name
- Sopheia/Mp Digitoxin Eia Kit
- Applicant
- Diagnostic Products Corp.
Mchenry, IL, US - Received
- July 3, 1984
- Decision date
- August 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
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Questions and answers
When was Sopheia/Mp Digitoxin Eia Kit cleared by the FDA?
Sopheia/Mp Digitoxin Eia Kit (K842578) received a 510(k) decision of Substantially Equivalent on August 12, 1984, 40 days after the submission was received.
What is the product code of K842578?
The FDA product code is LFM – Enzyme Immunoassay, Digitoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3300.