The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Optiphor-10.
| Device ID | K842560 |
| 510k Number | K842560 |
| Device Name: | OPTIPHOR-10 |
| 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 | 1984-07-02 |
| Decision Date | 1984-08-10 |