The following data is part of a premarket notification filed by Scientific Device Laboratory, Inc. with the FDA for Gram Stain Control Slide.
| Device ID | K890718 |
| 510k Number | K890718 |
| Device Name: | GRAM STAIN CONTROL SLIDE |
| Classification | Quality Control Slides |
| Applicant | SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
| Contact | Lipton Ph.d. |
| Correspondent | Lipton Ph.d. SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
| Product Code | LJG |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-13 |
| Decision Date | 1989-03-16 |