FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
125-I TSH RECEPTOR ANTIBODY KIT
K Number: K863006
·
Decision Sep 8, 1986
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
90
Applicant Total
3
Review Days
31
Basic Information
- Device Name
- 125-I TSH RECEPTOR ANTIBODY KIT
- K Number
- K863006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- CRONUS
- Date Received
- August 8, 1986
- Decision Date
- September 8, 1986
- Product Code
- JZO
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | FDA class 2 | Immunology |
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