The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Hemoglobin Electrophoresis Control.
| Device ID | K810919 |
| 510k Number | K810919 |
| Device Name: | HEMOGLOBIN ELECTROPHORESIS CONTROL |
| Classification | System, Analysis, Electrophoretic Hemoglobin |
| Applicant | ISOLAB, INC. 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 | 1981-04-06 |
| Decision Date | 1981-04-23 |