The following data is part of a premarket notification filed by Biorent Diagnostic, Inc. with the FDA for Hemoglobin Reagent.
| Device ID | K823060 |
| 510k Number | K823060 |
| Device Name: | HEMOGLOBIN REAGENT |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | BIORENT DIAGNOSTIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-18 |
| Decision Date | 1982-11-22 |