Cedia Digitoxin Assay
FDA 510(k) K896021 · Microgenics Corp.
510(k) numberK896021
Submission
- Device name
- Cedia Digitoxin Assay
- Applicant
- Microgenics Corp.
Concord, CA, US - Received
- October 16, 1989
- Decision date
- November 8, 1989
- 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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| 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 |
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Questions and answers
When was Cedia Digitoxin Assay cleared by the FDA?
Cedia Digitoxin Assay (K896021) received a 510(k) decision of Substantially Equivalent on November 8, 1989, 23 days after the submission was received.
What is the product code of K896021?
The FDA product code is LFM – Enzyme Immunoassay, Digitoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3300.