The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Quantikine Ivd Stfr Enzyme Linked Immunosorbent Assay (elisa).
| Device ID | K970718 |
| 510k Number | K970718 |
| Device Name: | QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) |
| Classification | Immunochemical, Transferrin |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Kenneth T Edds, Ph.d. |
| Correspondent | Kenneth T Edds, Ph.d. R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | JNM |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-26 |
| Decision Date | 1997-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762021657 | K970718 | 000 |