FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THYROGLOBULIN ANTIBODY ELISA
K Number: K960370
·
Decision Jun 20, 1996
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
55
Review Days
147
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Basic Information
- Device Name
- THYROGLOBULIN ANTIBODY ELISA
- K Number
- K960370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Immco Diagnostics, Inc.
- Date Received
- January 25, 1996
- Decision Date
- June 20, 1996
- 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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| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | Oct 25, 2013 | Substantially Equivalent |
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