Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge
FDA 510(k) K062024 · Dade Behring, Inc.
510(k) numberK062024
Submission
- Device name
- Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- July 18, 2006
- Decision date
- July 28, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| 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 |
| K915465 | Digitoxin Fpia Reagent SetLFM · Traditional | Sigma Diagnostics, Inc. | 01/27/1992SE |
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| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | 06/25/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
| K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional | 03/13/2008SE |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional | 02/26/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | 02/21/2008SE |
| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional | 01/03/2008SE |
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Questions and answers
When was Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge cleared by the FDA?
Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge (K062024) received a 510(k) decision of Substantially Equivalent on July 28, 2006, 10 days after the submission was received.
What is the product code of K062024?
The FDA product code is LFM – Enzyme Immunoassay, Digitoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3300.