FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAYER ADVIA CENTAUR CA 19-9 ASSAY
K Number: K031393
·
Decision Jun 24, 2003
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
10
Applicant Total
46
Review Days
53
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Basic Information
- Device Name
- BAYER ADVIA CENTAUR CA 19-9 ASSAY
- K Number
- K031393
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- May 2, 2003
- Decision Date
- June 24, 2003
- Product Code
- NIG
- 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 |
|---|---|---|---|
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NIG), ordered by most recent decision date.
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DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
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ARCHITECT CA 19-9XR ASSAY
FDA 510(k)
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