The following data is part of a premarket notification filed by Genepoc Inc. with the FDA for Genepoc Cdiff.
Device ID | K172569 |
510k Number | K172569 |
Device Name: | GenePOC CDiff |
Classification | C. Difficile Toxin Gene Amplification Assay |
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 | OZN |
CFR Regulation Number | 866.3130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-25 |
Decision Date | 2017-11-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00628055344025 | K172569 | 000 |
00628055344124 | K172569 | 000 |
00840733102349 | K172569 | 000 |