InSure ONE
Reagent, Occult Blood
Enterix Inc.
The following data is part of a premarket notification filed by Enterix Inc. with the FDA for Insure One.
Pre-market Notification Details
| Device ID | K170548 |
| 510k Number | K170548 |
| Device Name: | InSure ONE |
| Classification | Reagent, Occult Blood |
| Applicant | Enterix Inc. 236 Fernwood Avenue Edison, NJ 08837 |
| Contact | Michele Houldsworth |
| Correspondent | Ronald Schoengold E Gold Solutions Consulting 19000 Saratoga Glen Place Saratoga, CA 95070 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-24 |
| Decision Date | 2017-10-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850093003354 | K170548 | 000 |
| 00850093003347 | K170548 | 000 |
| 30850093003317 | K170548 | 000 |
| 00850093003309 | K170548 | 000 |
| 00850093003293 | K170548 | 000 |
| 00850093003286 | K170548 | 000 |
| 00850093003279 | K170548 | 000 |
| 00850093003231 | K170548 | 000 |
Trademark Results [InSure ONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSURE ONE 74101998 2104486 Live/Registered |
INSUREONE INSURANCE SERVICES AMERICA, LLC 1990-10-01 |
 INSURE ONE 74101980 2104485 Live/Registered |
INSUREONE INSURANCE SERVICES AMERICA, LLC 1990-10-01 |
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