FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHALDEBAS DIGOXIN RIA
K Number: K770322
·
Decision Apr 5, 1977
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
14
Applicant Total
129
Review Days
47
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Basic Information
- Device Name
- PHALDEBAS DIGOXIN RIA
- K Number
- K770322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- February 17, 1977
- Decision Date
- April 5, 1977
- Product Code
- LCS
- 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 |
|---|---|---|---|
| LCS | Radioimmunoassay, Digoxin (125-I) | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
| K951025 | PISTON SYRINGE | Oct 19, 1995 | Substantially Equivalent |
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