The following data is part of a premarket notification filed by Genepoc Inc. with the FDA for Genepoc Gbs Lb.
| Device ID | K170557 |
| 510k Number | K170557 |
| Device Name: | GenePOC GBS LB |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 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 | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055344018 | K170557 | 000 |
| 00628055344117 | K170557 | 000 |
| 00840733102363 | K170557 | 000 |