The following data is part of a premarket notification filed by Remel Co. with the FDA for Germ Tube Solution.
| Device ID | K884720 |
| 510k Number | K884720 |
| Device Name: | GERM TUBE SOLUTION |
| Classification | Kit, Screening, Yeast |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Brenda Teply |
| Correspondent | Brenda Teply REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JXC |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-10 |
| Decision Date | 1989-06-02 |