FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K Number: K022177
·
Decision Dec 17, 2002
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
33
Applicant Total
32
Review Days
167
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Basic Information
- Device Name
- PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K Number
- K022177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Diagnostics Corp.
- Date Received
- July 3, 2002
- Decision Date
- December 17, 2002
- Product Code
- LTJ
- 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 |
|---|---|---|---|
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LTJ), ordered by most recent decision date.
Atellica IM Total PSA II (tPSAII)
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FREND PSA PLUS (REAGENT CARTRIDGE)
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FDA Class 2
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TPSA FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
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COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Bayer Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K033379 | BAYER SPECIAL CHEMISTRY CONTROLS | Dec 19, 2003 | Substantially Equivalent |
| K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS | Dec 16, 2003 | Substantially Equivalent |
| K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | Nov 14, 2003 | Substantially Equivalent |
| 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 |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Nov 27, 2002 | Substantially Equivalent |
| K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Nov 18, 2002 | Substantially Equivalent |