FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OREIA - DIGOXIN
K Number: K790521
·
Decision Apr 10, 1979
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
41
Review Days
25
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Basic Information
- Device Name
- OREIA - DIGOXIN
- K Number
- K790521
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Organon, Inc.
- Date Received
- March 16, 1979
- Decision Date
- April 10, 1979
- 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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RANDOX DIGOXIN ASSAY
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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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AXSYM DIGOXIN III
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Other Clearances by Organon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950861 | RECONSTITUTION ACCESSOREIS | May 26, 1995 | Substantially Equivalent |
| K853388 | MONOSTICON UNI-DOT | Aug 22, 1985 | Substantially Equivalent |
| K842314 | DUOCLON COLOR-CEPT | Aug 24, 1984 | Substantially Equivalent |
| K841525 | OREIA II B-HCG PREGNANCY TEST KIT | Jun 5, 1984 | Substantially Equivalent |
| K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT | May 22, 1984 | Substantially Equivalent |
| K840650 | B-NEOCEPT 30 | Apr 4, 1984 | Substantially Equivalent |
| K832801 | OREIA II B-HCG, ENZYME INNUNOASSAY | Dec 8, 1983 | Substantially Equivalent |
| K831339 | NEO-PREGNOSTICON DUOCLON TUBE TEST | Jun 8, 1983 | Substantially Equivalent |
| K831109 | DUOCLON SLIDE TEST | Jun 2, 1983 | Substantially Equivalent |
| K823682 | BETA FFIRM TEST | Jan 7, 1983 | Substantially Equivalent |