The following data is part of a premarket notification filed by Fmc Corp. with the FDA for Isogel Agarose.
| Device ID | K841407 |
| 510k Number | K841407 |
| Device Name: | ISOGEL AGAROSE |
| Classification | Apparatus, Electrophoresis, For Clinical Use |
| Applicant | FMC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | Pettiss |
| Correspondent | Pettiss FMC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJN |
| CFR Regulation Number | 862.2485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-04 |
| Decision Date | 1985-07-16 |