The following data is part of a premarket notification filed by W.h.p.m., Inc. with the FDA for Hemosure One-step Fecal Occult Blood Test.
| Device ID | K041202 |
| 510k Number | K041202 |
| Device Name: | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST |
| Classification | Reagent, Occult Blood |
| Applicant | W.H.P.M., INC. 163 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White W.H.P.M., INC. 163 CABOT ST. Beverly, MA 01915 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-07 |
| Decision Date | 2004-08-12 |
| Summary: | summary |