The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Sickle-cell F Test.
| Device ID | K791143 |
| 510k Number | K791143 |
| Device Name: | SICKLE-CELL F TEST |
| Classification | Assay, Fetal Hemoglobin |
| Applicant | ISOLAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KQI |
| CFR Regulation Number | 864.7455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-18 |
| Decision Date | 1979-07-17 |