Axsym Ca 125
FDA 510(k) K964020 · Abbott Laboratories
510(k) numberK964020
Submission
- Device name
- Axsym Ca 125
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- October 7, 1996
- Decision date
- November 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Axsym Ca 125 cleared by the FDA?
Axsym Ca 125 (K964020) received a 510(k) decision of Substantially Equivalent on November 4, 1997, 393 days after the submission was received.
What is the product code of K964020?
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.