The following data is part of a premarket notification filed by Remel Co. with the FDA for Calcofluor White Stain Kit.
| Device ID | K880718 |
| 510k Number | K880718 |
| Device Name: | CALCOFLUOR WHITE STAIN KIT |
| Classification | Stains, Microbiologic |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Brenda Henry |
| Correspondent | Brenda Henry 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 | 1988-02-23 |
| Decision Date | 1988-03-25 |