The following data is part of a premarket notification filed by Michclone Associates, Inc. with the FDA for Sickle-heme A/s Heterozygous Control.
| Device ID | K842955 |
| 510k Number | K842955 |
| Device Name: | SICKLE-HEME A/S HETEROZYGOUS CONTROL |
| Classification | Test, Sickle Cell |
| Applicant | MICHCLONE ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-27 |
| Decision Date | 1984-08-09 |