The following data is part of a premarket notification filed by W.h.p.m., Inc with the FDA for Hemosure Accu-reader A100.
| Device ID | K200754 |
| 510k Number | K200754 |
| Device Name: | Hemosure Accu-Reader A100 |
| Classification | Automated Occult Blood Analyzer |
| Applicant | W.H.P.M., Inc 5358 North Irwindale Avenue Irwindale, CA 91706 |
| Contact | Farokh Etemedieh |
| Correspondent | Farokh Etemadieh Smith Associates 5358 North Irwindale Avenue Irwindale, CA 91706 |
| Product Code | OOX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-23 |
| Decision Date | 2022-06-02 |