The following data is part of a premarket notification filed by Polysciences, Inc. with the FDA for Fungi Fluor Kit.
| Device ID | K923349 |
| 510k Number | K923349 |
| Device Name: | FUNGI FLUOR KIT |
| Classification | Pneumocystis Carinii |
| Applicant | POLYSCIENCES, INC. 400 VALLEY RD. Warrington, PA 18976 -2590 |
| Contact | Barbara Waggett |
| Correspondent | Barbara Waggett POLYSCIENCES, INC. 400 VALLEY RD. Warrington, PA 18976 -2590 |
| Product Code | LYF |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-08 |
| Decision Date | 1992-10-20 |