The following data is part of a premarket notification filed by Reagent Laboratory, Inc. with the FDA for Potassium Hydroxide 10% W/v.
| Device ID | K863550 |
| 510k Number | K863550 |
| Device Name: | POTASSIUM HYDROXIDE 10% W/V |
| Classification | General Purpose Reagent |
| Applicant | REAGENT LABORATORY, INC. 300 EAST OTTAWA AVE. Louisville, KY 40209 |
| Contact | Donald Skaggs |
| Correspondent | Donald Skaggs REAGENT LABORATORY, INC. 300 EAST OTTAWA AVE. Louisville, KY 40209 |
| Product Code | PPM |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-12 |
| Decision Date | 1986-10-02 |