Immulite Digitoxin
FDA 510(k) K943235 · Diagnostic Products Corp.
510(k) numberK943235
Submission
- Device name
- Immulite Digitoxin
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- July 6, 1994
- Decision date
- October 27, 1994
- 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 |
| 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 |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite Digitoxin cleared by the FDA?
Immulite Digitoxin (K943235) received a 510(k) decision of Substantially Equivalent on October 27, 1994, 113 days after the submission was received.
What is the product code of K943235?
The FDA product code is LFM – Enzyme Immunoassay, Digitoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3300.