The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Sickle Hb Assay.
| Device ID | K841170 |
| 510k Number | K841170 |
| Device Name: | SICKLE HB ASSAY |
| Classification | Test, Sickle Cell |
| Applicant | ISOLAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-04-04 |