The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay (elisa).
| Device ID | K936016 |
| 510k Number | K936016 |
| Device Name: | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) |
| Classification | Assay, Erythropoietin |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | John G Yager |
| Correspondent | John G Yager R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-16 |
| Decision Date | 1994-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762021640 | K936016 | 000 |