The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Gelman Lipoprotein Frs Set. P/n 51213.
| Device ID | K791606 |
| 510k Number | K791606 |
| Device Name: | GELMAN LIPOPROTEIN FRS SET. P/N 51213 |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-20 |
| Decision Date | 1979-09-17 |