FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K Number: K033007
·
Decision Nov 14, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
32
Review Days
49
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
- K Number
- K033007
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Diagnostics Corp.
- Date Received
- September 26, 2003
- Decision Date
- November 14, 2003
- Product Code
- KXT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RANDOX DIGOXIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 Bayer Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K033379 | BAYER SPECIAL CHEMISTRY CONTROLS | Dec 19, 2003 | Substantially Equivalent |
| K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS | Dec 16, 2003 | Substantially Equivalent |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | Sep 4, 2003 | Substantially Equivalent |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Mar 18, 2003 | Substantially Equivalent |
| K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | Mar 3, 2003 | Substantially Equivalent |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | Jan 7, 2003 | Substantially Equivalent |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Dec 24, 2002 | Substantially Equivalent |
| K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 17, 2002 | Substantially Equivalent |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Nov 27, 2002 | Substantially Equivalent |
| K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Nov 18, 2002 | Substantially Equivalent |