The following data is part of a premarket notification filed by Scientific Device Laboratory, Inc. with the FDA for Turbidometric Standard.
| Device ID | K911059 |
| 510k Number | K911059 |
| Device Name: | TURBIDOMETRIC STANDARD |
| Classification | Reagent/device, Inoculum Calibration |
| Applicant | SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
| Contact | Stewart Lipton |
| Correspondent | Stewart Lipton SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
| Product Code | LIE |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1991-06-10 |