The following data is part of a premarket notification filed by Litmus Concepts, Inc. with the FDA for Femexam Testcard.
| Device ID | K962718 |
| 510k Number | K962718 |
| Device Name: | FEMEXAM TESTCARD |
| Classification | Dye-indicator, Ph (urinary, Non-quantitative) |
| 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 | CEN |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-12 |
| Decision Date | 1997-02-07 |
| Summary: | summary |