The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Rapid Yeast Plus System.
| Device ID | K943621 |
| 510k Number | K943621 |
| Device Name: | RAPID YEAST PLUS SYSTEM |
| Classification | Kit, Identification, Yeast |
| Applicant | INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
| Contact | Louis A Eriquez, Ph.d. |
| Correspondent | Louis A Eriquez, Ph.d. INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
| Product Code | JXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-27 |
| Decision Date | 1995-01-27 |