Quantikine IVD STFR Enzyme Linked Immunosorbent Assay (Elisa)
FDA 510(k) K970718 · R&D Systems, Inc.
510(k) numberK970718
Submission
- Device name
- Quantikine IVD STFR Enzyme Linked Immunosorbent Assay (Elisa)
- Applicant
- R&D Systems, Inc.
Minneapolis, MN, US - Received
- February 26, 1997
- Decision date
- May 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JNM – Immunochemical, Transferrin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
Other 510(k)s with product code JNM
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Questions and answers
When was Quantikine IVD STFR Enzyme Linked Immunosorbent Assay (Elisa) cleared by the FDA?
Quantikine IVD STFR Enzyme Linked Immunosorbent Assay (Elisa) (K970718) received a 510(k) decision of Substantially Equivalent on May 27, 1997, 90 days after the submission was received.
What is the product code of K970718?
The FDA product code is JNM – Immunochemical, Transferrin, a Class II (moderate risk) device regulated under 21 CFR 866.5880.