FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGOXIN RIA ASSAY
K Number: K810296
·
Decision Feb 19, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
16
Applicant Total
7
Review Days
15
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Basic Information
- Device Name
- DIGOXIN RIA ASSAY
- K Number
- K810296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Ria Diagnostics
- Date Received
- February 4, 1981
- Decision Date
- February 19, 1981
- Product Code
- DON
- 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 |
|---|---|---|---|
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DON), ordered by most recent decision date.
CIBA CORNING ACS DIGOXIN IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
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FDA Class 2
·Clinical Toxicology
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
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FDA Class 2
·Clinical Toxicology
PHASE II DIGOXIN RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ZETAPHASE-DIG
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ENZYMUNE-TEST DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Ria Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K855033 | T-3 UPTAKE/RIASSAY | Jan 24, 1986 | Substantially Equivalent |
| K854798 | T-4 RIASSAY | Jan 15, 1986 | Substantially Equivalent |
| K852537 | T-3 RIASSAY | Aug 12, 1985 | Substantially Equivalent |
| K801691 | TSH RIASSAY | Aug 27, 1980 | Substantially Equivalent |
| K792062 | THEOPHYLLINE RIASSAY | Feb 25, 1980 | Substantially Equivalent |
| K780012 | ANTITHROMBIN III RIA | Jan 20, 1978 | Substantially Equivalent |