The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Sickle Cell Solubility Test Kit.
| Device ID | K895745 |
| 510k Number | K895745 |
| Device Name: | SICKLE CELL SOLUBILITY TEST KIT |
| Classification | Solubility, Hemoglobin, Abnormal |
| Applicant | SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Contact | Carl R Burks |
| Correspondent | Carl R Burks SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Product Code | JBB |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-11-29 |