The following data is part of a premarket notification filed by Enterix Inc. with the FDA for !nsure Fecal Occult Blood Test.
| Device ID | K002457 |
| 510k Number | K002457 |
| Device Name: | !NSURE FECAL OCCULT BLOOD TEST |
| Classification | Reagent, Occult Blood |
| Applicant | ENTERIX INC. 348 US ROUTE ONE Falmouth,, ME 04105 |
| Contact | Robert C Bruce |
| Correspondent | Robert C Bruce ENTERIX INC. 348 US ROUTE ONE Falmouth,, ME 04105 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-10 |
| Decision Date | 2001-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850093003187 | K002457 | 000 |
| 00850093003095 | K002457 | 000 |
| 10850093003085 | K002457 | 000 |
| 00850093003071 | K002457 | 000 |
| 00850093003064 | K002457 | 000 |
| 00850093003040 | K002457 | 000 |
| 00850093003019 | K002457 | 000 |