The Ca 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)
FDA 510(k) K964703 · Bayer Corp.
510(k) numberK964703
Submission
- Device name
- The Ca 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)
- Applicant
- Bayer Corp.
Tarrytown, NY, US - Received
- November 22, 1996
- Decision date
- December 1, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOI – System, Test, Immunological, Antigen, Tumor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
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Questions and answers
When was The Ca 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System) cleared by the FDA?
The Ca 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System) (K964703) received a 510(k) decision of Substantially Equivalent on December 1, 1997, 374 days after the submission was received.
What is the product code of K964703?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.