FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
K Number: K003291
·
Decision Dec 5, 2000
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
32
Review Days
46
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Basic Information
- Device Name
- BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
- K Number
- K003291
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Diagnostics Corp.
- Date Received
- October 20, 2000
- Decision Date
- December 5, 2000
- 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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Other Clearances by Bayer Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | Sep 4, 2003 | Substantially Equivalent |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Mar 18, 2003 | Substantially Equivalent |
| K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | Mar 3, 2003 | Substantially Equivalent |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | Jan 7, 2003 | Substantially Equivalent |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Dec 24, 2002 | Substantially Equivalent |
| K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 17, 2002 | Substantially Equivalent |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Nov 27, 2002 | Substantially Equivalent |