The following data is part of a premarket notification filed by Val Tech Diagnostics, Inc. with the FDA for Histo-check Fungal Control Slides.
| Device ID | K883570 |
| 510k Number | K883570 |
| Device Name: | HISTO-CHECK FUNGAL CONTROL SLIDES |
| Classification | Quality Control Slides |
| Applicant | VAL TECH DIAGNOSTICS, INC. 14 WERNER CAMP RD. Pittsburgh, PA 15215 |
| Contact | Steve L Sinka |
| Correspondent | Steve L Sinka VAL TECH DIAGNOSTICS, INC. 14 WERNER CAMP RD. Pittsburgh, PA 15215 |
| Product Code | LJG |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-22 |
| Decision Date | 1988-10-06 |