FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K Number: K023891
·
Decision Dec 6, 2002
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
25
Applicant Total
41
Review Days
14
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Basic Information
- Device Name
- ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
- K Number
- K023891
- 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 6, 2002
- Product Code
- LTK
- 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 |
|---|---|---|---|
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | FDA class 2 | Immunology |
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Other Clearances by Tosoh Medics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Dec 18, 2002 | Substantially Equivalent |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Dec 17, 2002 | Substantially Equivalent |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | Dec 17, 2002 | Substantially Equivalent |
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | May 14, 2002 | Substantially Equivalent |
| K012820 | AIA-PACK CTNI 2ND-GEN ASSAY | Dec 14, 2001 | Substantially Equivalent |
| K011434 | G7 AUTOMATED HPLC ANALYZER | Sep 18, 2001 | Substantially Equivalent |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Aug 16, 2001 | Substantially Equivalent |
| 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 |