FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAT-A-COUNT DIGITOXIN RIA KIT
K Number: K812129
·
Decision Aug 13, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
321
Review Days
17
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Basic Information
- Device Name
- COAT-A-COUNT DIGITOXIN RIA KIT
- K Number
- K812129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3300
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Products Corp.
- Date Received
- July 27, 1981
- Decision Date
- August 13, 1981
- Product Code
- DPG
- 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 |
|---|---|---|---|
| DPG | Radioimmunoassay, Digitoxin (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 (DPG), ordered by most recent decision date.
OPUS DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RIALYZE DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | Aug 21, 2002 | Substantially Equivalent |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 | Substantially Equivalent |
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