Revogene
Real Time Nucleic Acid Amplification System
GenePOC Inc.
The following data is part of a premarket notification filed by Genepoc Inc. with the FDA for Revogene.
Pre-market Notification Details
| Device ID | K170558 |
| 510k Number | K170558 |
| Device Name: | Revogene |
| Classification | Real Time Nucleic Acid Amplification System |
| Applicant | GenePOC Inc. 360 Rue Franquet Quebec, CA G1p 4n3 |
| Contact | Guy Sevigny |
| Correspondent | Guy Sevigny GenePOC Inc. 360 Rue Franquet Quebec, CA G1p 4n3 |
| Product Code | OOI |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-24 |
| Decision Date | 2017-05-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055344032 | K170558 | 000 |
| 00628055344001 | K170558 | 000 |
| 00628055344131 | K170558 | 000 |
| 00628055344100 | K170558 | 000 |
| 00840733102318 | K170558 | 000 |
Trademark Results [Revogene]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVOGENE 87514391 5784546 Live/Registered |
Genepoc Inc. 2017-07-03 |
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