The following data is part of a premarket notification filed by Macomb Biotechnology, Inc. with the FDA for Modified Hemoglobin Reagent Set.
| Device ID | K894951 |
| 510k Number | K894951 |
| Device Name: | MODIFIED HEMOGLOBIN REAGENT SET |
| Classification | Cyanomethemoglobin |
| Applicant | MACOMB BIOTECHNOLOGY, INC. 70001 POWELL RD, P.O. BOX 466 Romeo, MI 48065 |
| Contact | Peggy Mounts |
| Correspondent | Peggy Mounts MACOMB BIOTECHNOLOGY, INC. 70001 POWELL RD, P.O. BOX 466 Romeo, MI 48065 |
| Product Code | GKK |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-10-24 |