FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K Number: K012777
·
Decision Oct 22, 2001
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
96
Review Days
63
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Basic Information
- Device Name
- ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
- K Number
- K012777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- August 20, 2001
- Decision Date
- October 22, 2001
- 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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