The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for Rf Controls.
| Device ID | K790986 |
| 510k Number | K790986 |
| Device Name: | RF CONTROLS |
| Classification | Solution, M-nitrophenol, Specific Reagent For Cholinesterase |
| Applicant | WAMPOLE LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DMR |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-25 |
| Decision Date | 1979-06-28 |