ST Aia-Pack Ca 125 Enzyme Immunoassay
FDA 510(k) K023891 · Tosoh Medics, Inc.
510(k) numberK023891
Submission
- Device name
- ST Aia-Pack Ca 125 Enzyme Immunoassay
- Applicant
- Tosoh Medics, Inc.
South San Francisco, CA, US - Received
- November 22, 2002
- Decision date
- December 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
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More from Siemens Medical Solutions Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K023893 | ST Aia-Pack Cea Enzyme ImmunoassayDHX · Special | 12/18/2002SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | 12/17/2002SE |
| K023091 | ST Aia-Pack Testosterone AssayCDZ · Traditional | 12/17/2002SE |
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | 05/14/2002SE |
| K012820 | Aia-Pack Ctni 2ND-GEN AssayMMI · Traditional | 12/14/2001SE |
| K011434 | G7 Automated HPLC AnalyzerLCP · Traditional | 09/18/2001SE |
| K010796 | Aia-Pack Brca, ST Aia Pack BrcaMOI · Traditional | 08/16/2001SE |
| K992365 | Aia-Pack Folate AssayCGN · Traditional | 08/10/1999SE |
| K990431 | Aia-Pack Ca 125LTK · Traditional | 06/03/1999SE |
| K991252 | Aia-Pack FT3 AssayCDP · Traditional | 05/11/1999SE |
Questions and answers
When was ST Aia-Pack Ca 125 Enzyme Immunoassay cleared by the FDA?
ST Aia-Pack Ca 125 Enzyme Immunoassay (K023891) received a 510(k) decision of Substantially Equivalent on December 6, 2002, 14 days after the submission was received.
What is the product code of K023891?
The FDA product code is LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125), a Class II (moderate risk) device regulated under 21 CFR 866.6010.