The following data is part of a premarket notification filed by Omega Medical Electronics with the FDA for Hemoglobin Reagent Set.
| Device ID | K821202 |
| 510k Number | K821202 |
| Device Name: | HEMOGLOBIN REAGENT SET |
| Classification | Cyanomethemoglobin |
| Applicant | OMEGA MEDICAL ELECTRONICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GKK |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-05-24 |