FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAS DIGOXIN (DIG)
K Number: K932250
·
Decision Sep 10, 1993
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
49
Review Days
123
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Basic Information
- Device Name
- VIDAS DIGOXIN (DIG)
- K Number
- K932250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerieux Vitek, Inc.
- Date Received
- May 10, 1993
- Decision Date
- September 10, 1993
- Product Code
- KXT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KXT | Enzyme Immunoassay, Digoxin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXT), ordered by most recent decision date.
ADVIA Centaur® Digoxin assay
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Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
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RANDOX DIGOXIN ASSAY
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DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AXSYM DIGOXIN III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Biomerieux Vitek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973819 | VIDAS D-DIMER (DD) ASSAY | Mar 10, 1998 | Substantially Equivalent |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Oct 3, 1997 | Substantially Equivalent |
| K965092 | VIDAS ROTAVIRUS ASSAY | May 5, 1997 | Substantially Equivalent |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Apr 8, 1997 | Substantially Equivalent |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Oct 7, 1996 | Substantially Equivalent |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Aug 30, 1996 | Substantially Equivalent |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Aug 30, 1996 | Substantially Equivalent |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 | Substantially Equivalent |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Feb 6, 1996 | Substantially Equivalent |
| K943812 | VIDAS LYME SCREEN II | Jun 13, 1995 | Substantially Equivalent |