Architect Ca 125 II Assay
FDA 510(k) K042731 · Fujirebio Diagnostics,Inc.
510(k) numberK042731
Submission
- Device name
- Architect Ca 125 II Assay
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- October 1, 2004
- Decision date
- November 19, 2004
- 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 Architect Ca 125 II Assay cleared by the FDA?
Architect Ca 125 II Assay (K042731) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 49 days after the submission was received.
What is the product code of K042731?
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.