The following data is part of a premarket notification filed by Zaxis, Inc. with the FDA for Lfs Lipogel Assay Kit.
| Device ID | K960785 |
| 510k Number | K960785 |
| Device Name: | LFS LIPOGEL ASSAY KIT |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | ZAXIS, INC. 1890 GEORGETOWN RD. Hudson, OH 44236 |
| Contact | Kenneth W Egger |
| Correspondent | Kenneth W Egger ZAXIS, INC. 1890 GEORGETOWN RD. Hudson, OH 44236 |
| Product Code | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-26 |
| Decision Date | 1996-09-03 |
| Summary: | summary |