The following data is part of a premarket notification filed by Litmus Concepts, Inc. with the FDA for Indicard Test.
| Device ID | K964015 |
| 510k Number | K964015 |
| Device Name: | INDICARD TEST |
| Classification | Dna Probe, Gardnerella Vaginalis |
| Applicant | LITMUS CONCEPTS, INC. P.O. BOX 296 Front Royal, VA 22630 |
| Contact | Suzanne Parisian |
| Correspondent | Suzanne Parisian LITMUS CONCEPTS, INC. P.O. BOX 296 Front Royal, VA 22630 |
| Product Code | MJM |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-06-19 |