The following data is part of a premarket notification filed by Genepoc Inc. with the FDA for Genepoc Carba.
| Device ID | K190275 |
| 510k Number | K190275 |
| Device Name: | GenePOC Carba |
| Classification | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony |
| Applicant | GenePOC Inc. 360 Rue Franquet Quebec, CA G1p 4n3 |
| Contact | Dany Leblanc |
| Correspondent | Dany Leblanc GenePOC Inc. 360 Rue Franquet Quebec, CA G1p 4n3 |
| Product Code | PMY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055344070 | K190275 | 000 |
| 00628055344162 | K190275 | 000 |
| 00840733102370 | K190275 | 000 |