The following data is part of a premarket notification filed by Michclone Associates, Inc. with the FDA for Sickle Cell Reagent Set.
| Device ID | K860812 |
| 510k Number | K860812 |
| Device Name: | SICKLE CELL REAGENT SET |
| Classification | Test, Sickle Cell |
| Applicant | MICHCLONE ASSOCIATES, INC. 15003 W 8 MILE Detroit, MI 48235 |
| Contact | Toben, Phd |
| Correspondent | Toben, Phd MICHCLONE ASSOCIATES, INC. 15003 W 8 MILE Detroit, MI 48235 |
| Product Code | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-04-11 |