FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECLIPSE ICA DIGOXIN
K Number: K905719
·
Decision Jan 17, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
13
Applicant Total
7
Review Days
27
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Basic Information
- Device Name
- ECLIPSE ICA DIGOXIN
- K Number
- K905719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Biotope, Inc.
- Date Received
- December 21, 1990
- Decision Date
- January 17, 1991
- Product Code
- DPO
- 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 |
|---|---|---|---|
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPO), ordered by most recent decision date.
IMMULITE DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RIA COAT DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SOPHEIA DIGOXIN EIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMMUCHEM COVALENT-COAT RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COAT-A-COUNT DIGOXIN RIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Biotope, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905145 | ECLIPSE ICA CHOLESTEROL | Feb 26, 1991 | Substantially Equivalent |
| K910256 | ECLIPSE ICA TSH | Feb 22, 1991 | Substantially Equivalent |
| K910302 | ECLIPSE ICA ANALYZER | Feb 22, 1991 | Substantially Equivalent |
| K905601 | ECLIPSE ICA TRIGLYCERIDES | Jan 17, 1991 | Substantially Equivalent |
| K905602 | ECLIPSE ICA BUN | Jan 16, 1991 | Substantially Equivalent |
| K905144 | ECLIPSE ICA GLUCOSE | Jan 4, 1991 | Substantially Equivalent |