FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K Number: K023894
·
Decision Dec 17, 2002
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
16
Applicant Total
41
Review Days
25
Basic Information
- Device Name
- ST AIA-PACK AFP ENZYME IMMUNOASSAY
- K Number
- K023894
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TOSOH MEDICS, INC.
- Date Received
- November 22, 2002
- Decision Date
- December 17, 2002
- Product Code
- LOJ
- 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 |
|---|---|---|---|
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | FDA class 2 | Immunology |
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FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by TOSOH MEDICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | Dec 17, 2002 | Substantially Equivalent |
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| K992365 | AIA-PACK FOLATE ASSAY | Aug 10, 1999 | Substantially Equivalent |
| K990431 | AIA-PACK CA 125 | Jun 3, 1999 | Substantially Equivalent |
| K991252 | AIA-PACK FT3 ASSAY | May 11, 1999 | Substantially Equivalent |