The following data is part of a premarket notification filed by Mds Laboratories, Inc. with the FDA for Garnerella Vaginalis Identification Kit.
| Device ID | K864244 |
| 510k Number | K864244 |
| Device Name: | GARNERELLA VAGINALIS IDENTIFICATION KIT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | MDS LABORATORIES, INC. 2200 SOUTH SHERIDAN WAY MISSISSAUGA, ONT. L5j 2m4, CA |
| Contact | William Gastle |
| Correspondent | William Gastle MDS LABORATORIES, INC. 2200 SOUTH SHERIDAN WAY MISSISSAUGA, ONT. L5j 2m4, CA |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-28 |
| Decision Date | 1987-03-31 |