The following data is part of a premarket notification filed by Genepoc Inc. with the FDA for Genepoc Strep A.
| Device ID | K183366 |
| 510k Number | K183366 |
| Device Name: | GenePOC Strep A |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| 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 | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-04 |
| Decision Date | 2019-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055344087 | K183366 | 000 |
| 00628055344179 | K183366 | 000 |