K200754 is an FDA 510(k) clearance for the Hemosure Accu-Reader A100. This device is classified as a Automated Occult Blood Analyzer (Class II - Special Controls, product code OOX).
Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on June 2, 2022, 801 days after receiving the submission on March 23, 2020.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550. The Automated Test System Is Intended For The Qualitative Detection Of Fecal Occult Blood In Feces By Professional Laboratories. The Automated Test Is Used For The Determination Of Gastrointestinal Bleeding..
| 510(k) Number | K200754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2020 |
| Decision Date | June 02, 2022 |
| Days to Decision | 801 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | OOX - Automated Occult Blood Analyzer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |
| Definition | The Automated Test System Is Intended For The Qualitative Detection Of Fecal Occult Blood In Feces By Professional Laboratories. The Automated Test Is Used For The Determination Of Gastrointestinal Bleeding. |