The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Hi-phore High Resolution Electrophores.
| Device ID | K821303 |
| 510k Number | K821303 |
| Device Name: | HI-PHORE HIGH RESOLUTION ELECTROPHORES |
| Classification | Apparatus, Electrophoresis, For Clinical Use |
| Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJN |
| CFR Regulation Number | 862.2485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-04 |
| Decision Date | 1982-05-12 |