The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Quik-sep Hemoglobin F Assay & Control.
| Device ID | K820630 |
| 510k Number | K820630 |
| Device Name: | QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL |
| Classification | Hemoglobin F Quantitation |
| Applicant | ISOLAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JPC |
| CFR Regulation Number | 864.7455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-06-25 |