The following data is part of a premarket notification filed by Sekisui Diagnostics, Llc with the FDA for Osom Ifob 25 Test And Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test Kit.
| Device ID | K121397 |
| 510k Number | K121397 |
| Device Name: | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT |
| Classification | Reagent, Occult Blood |
| Applicant | SEKISUI DIAGNOSTICS, LLC 6659 Top Gun St San Diego, CA 92121 |
| Contact | Mark Stavro |
| Correspondent | Mark Stavro SEKISUI DIAGNOSTICS, LLC 6659 Top Gun St San Diego, CA 92121 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-09 |
| Decision Date | 2012-12-28 |
| Summary: | summary |