The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Labile Removing Hemolyzing Reagent.
| Device ID | K830804 |
| 510k Number | K830804 |
| Device Name: | LABILE REMOVING HEMOLYZING REAGENT |
| Classification | System, Analysis, Electrophoretic Hemoglobin |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBD |
| CFR Regulation Number | 864.7440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-14 |
| Decision Date | 1983-05-04 |