FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K Number: K022288
·
Decision Dec 17, 2002
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
33
Applicant Total
96
Review Days
155
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Basic Information
- Device Name
- COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
- K Number
- K022288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- July 15, 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
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TPSA FLEX REAGENT CARTRIDGE
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PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
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VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
FDA 510(k)
FDA Class 2
·Immunology
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| K Number | Device Name | ||
|---|---|---|---|
| K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER | Mar 3, 2003 | Substantially Equivalent |
| K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | Feb 11, 2003 | Substantially Equivalent |
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | Jan 30, 2003 | Substantially Equivalent |
| K024234 | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL | Jan 23, 2003 | Substantially Equivalent |
| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | Nov 20, 2002 | Substantially Equivalent |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Jul 24, 2002 | Substantially Equivalent |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | Jul 5, 2002 | Substantially Equivalent |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Mar 27, 2002 | Substantially Equivalent |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 21, 2001 | Substantially Equivalent |
| K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM | Dec 6, 2001 | Substantially Equivalent |