The following data is part of a premarket notification filed by Remel Co. with the FDA for Bactidrop Koh (10%).
| Device ID | K920970 |
| 510k Number | K920970 |
| Device Name: | BACTIDROP KOH (10%) |
| Classification | Stains, Microbiologic |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Ann Silvius |
| Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1992-06-09 |