The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Resolve-hb.
| Device ID | K840011 |
| 510k Number | K840011 |
| Device Name: | RESOLVE-HB |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | ISOLAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-04 |
| Decision Date | 1984-02-04 |