510(k) K970718
K970718 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)". The FDA issued a decision of Substantially Equivalent on May 27, 1997. The device falls under product code JNM (Immunochemical, Transferrin), a Class II device regulated under 21 CFR 866.5880. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1997
- Date Received
- February 26, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunochemical, Transferrin
- Device Class
- Class II
- Regulation Number
- 866.5880
- Review Panel
- IM
- Submission Type