The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Electrophoresis Reagent Set, Hdl.
| Device ID | K790791 |
| 510k Number | K790791 |
| Device Name: | ELECTROPHORESIS REAGENT SET, HDL |
| Classification | Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBT |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-24 |
| Decision Date | 1979-06-15 |