FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
K Number: K024017
·
Decision Jan 30, 2003
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
96
Review Days
57
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Basic Information
- Device Name
- BAYER ADVIA CENTAUR HER-2/NEU ASSAY
- K Number
- K024017
- 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
- December 4, 2002
- Decision Date
- January 30, 2003
- Product Code
- NCW
- 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 |
|---|---|---|---|
| NCW | System, Test, Her-2/Neu, Monitoring | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NCW), ordered by most recent decision date.
BAYER IMMUNO 1 HER-2/NEU ASSAY
FDA 510(k)
FDA Class 2
·Immunology
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
FDA 510(k)
FDA Class 2
·Immunology
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|---|---|---|---|
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| 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 |