The following data is part of a premarket notification filed by Ng Biotech with the FDA for Ng-test Carba 5.
| Device ID | K191889 |
| 510k Number | K191889 |
| Device Name: | NG-Test CARBA 5 |
| Classification | Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates |
| Applicant | NG Biotech Z.A. Courbouton, Secteur 1, Atelier Relais Le Tremplin Guipry, FR 35480 |
| Contact | Milovan Stankov-puges |
| Correspondent | Anna Klavins Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 |
| Product Code | PTJ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2019-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701077400133 | K191889 | 000 |