The following data is part of a premarket notification filed by Scientific Device Laboratory, Inc. with the FDA for Parasafe(r) Fixative.
| Device ID | K935316 |
| 510k Number | K935316 |
| Device Name: | PARASAFE(R) FIXATIVE |
| Classification | Device, Parasite Concentration |
| 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 | LKS |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-02 |
| Decision Date | 1994-02-17 |