The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Quantikine(tm) Erythropoietin Human Serum Controls.
| Device ID | K931756 |
| 510k Number | K931756 |
| Device Name: | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS |
| Classification | Assay, Erythropoietin |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Karyn Steere |
| Correspondent | Karyn Steere 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 | 1993-04-08 |
| Decision Date | 1994-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762021671 | K931756 | 000 |