The following data is part of a premarket notification filed by Remel Co. with the FDA for Bactidrop Calcofluor White.
| Device ID | K960095 |
| 510k Number | K960095 |
| Device Name: | BACTIDROP CALCOFLUOR WHITE |
| Classification | Stains, Microbiologic |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Mary Ann Slivius |
| Correspondent | Mary Ann Slivius 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 | 1996-01-11 |
| Decision Date | 1996-03-19 |