The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Enterix Insurefit Fob Controls, Model 16800.
| Device ID | K101831 |
| 510k Number | K101831 |
| Device Name: | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 |
| Classification | Control, Fecal Occult Blood |
| Applicant | BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01434 |
| Contact | Minna Rannikko |
| Correspondent | Minna Rannikko BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01434 |
| Product Code | OSL |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850093003033 | K101831 | 000 |