The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Histopaque-1077.
| Device ID | K842146 |
| 510k Number | K842146 |
| Device Name: | HISTOPAQUE-1077 |
| Classification | Lymphocyte Separation Medium |
| Applicant | SIGMA CHEMICAL CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-07-27 |