The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Hycel Quick-lysing Hemoglobin Reagent.
| Device ID | K882490 |
| 510k Number | K882490 |
| Device Name: | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT |
| Classification | Diluent, Blood Cell |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Karen Viskochil |
| Correspondent | Karen Viskochil R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | GIF |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-16 |
| Decision Date | 1988-07-25 |