The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for On The Spot Candidasure.
| Device ID | K883118 |
| 510k Number | K883118 |
| Device Name: | ON THE SPOT CANDIDASURE |
| Classification | Candida Spp., Direct Antigen, Id |
| Applicant | MEDI-TECH, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Contact | Julie Demarco |
| Correspondent | Julie Demarco MEDI-TECH, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Product Code | LRF |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-25 |
| Decision Date | 1988-09-30 |