FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED FREE T4 RADIOIMMUNOASSAY KIT
K Number: K884753
·
Decision Feb 27, 1989
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
91
Applicant Total
4
Review Days
105
Basic Information
- Device Name
- MODIFIED FREE T4 RADIOIMMUNOASSAY KIT
- K Number
- K884753
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- ADVANCED MAGNETICS, INC.
- Date Received
- November 14, 1988
- Decision Date
- February 27, 1989
- Product Code
- CEC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | Clinical Chemistry |
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