FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
K Number: K864333
·
Decision Jan 5, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
19
Review Days
62
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Basic Information
- Device Name
- DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
- K Number
- K864333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Windsor Laboratories, Inc.
- Date Received
- November 4, 1986
- Decision Date
- January 5, 1987
- Product Code
- KXT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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.
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DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
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ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
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Other Clearances by Windsor Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873281 | CARBAMAZEPINE (FPIA) CALIBRATOR KIT | Oct 28, 1987 | Substantially Equivalent |
| K873282 | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY | Sep 22, 1987 | Substantially Equivalent |
| K871486 | (FPIA) ASSAY BUFFER | May 8, 1987 | Substantially Equivalent |
| K870389 | DIGOXIN (FPIA) CALIBRATOR KIT | Apr 1, 1987 | Substantially Equivalent |
| K870390 | PHENOBARBITAL (FPIA) CALIBRATOR KIT | Apr 1, 1987 | Substantially Equivalent |
| K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | Nov 10, 1986 | Substantially Equivalent |
| K863244 | AMIKACIN (FPIA) CALIBRATOR KIT | Aug 29, 1986 | Substantially Equivalent |
| K862248 | AMIKACIN KIT (FPIA) | Aug 4, 1986 | Substantially Equivalent |
| K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT | Jun 25, 1986 | Substantially Equivalent |
| K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT | Jun 25, 1986 | Substantially Equivalent |