FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ST AIA-PACK CA 19-9
K Number: K023240
·
Decision Dec 23, 2002
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
10
Applicant Total
11
Review Days
87
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Basic Information
- Device Name
- ST AIA-PACK CA 19-9
- K Number
- K023240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tosoh Corp.
- Date Received
- September 27, 2002
- Decision Date
- December 23, 2002
- 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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VITROS CA 19-9
FDA 510(k)
FDA Class 2
·Immunology
ARCHITECT CA 19-9XR ASSAY
FDA 510(k)
FDA Class 2
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Other Clearances by Tosoh Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023239 | AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Jul 21, 1992 | Substantially Equivalent |
| K913663 | AIA-PACK T-U | Sep 30, 1991 | Substantially Equivalent |
| K913298 | AIA-PACK CK-MB | Sep 27, 1991 | Substantially Equivalent |
| K913493 | AIA-PACK FT4 | Sep 10, 1991 | Substantially Equivalent |
| K903628 | AIA-PACK IRI | Sep 7, 1990 | Substantially Equivalent |
| K901965 | MPR-4A - MICRO-PLATE READER | May 10, 1990 | Substantially Equivalent |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | May 2, 1990 | Substantially Equivalent |
| K897001 | TOSOH AIA-PACK T3 | Mar 9, 1990 | Substantially Equivalent |
| K896982 | AIA-PACK T4 | Mar 9, 1990 | Substantially Equivalent |