The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Gc Base W/ 1% Gchi.
| Device ID | K954986 |
| 510k Number | K954986 |
| Device Name: | GC BASE W/ 1% GCHI |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | REMEL, L.P. 12076 SANTA FE DR. Lenexa, KS 66215 -3594 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius REMEL, L.P. 12076 SANTA FE DR. Lenexa, KS 66215 -3594 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-31 |
| Decision Date | 1996-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838004469 | K954986 | 000 |
| 00848838001796 | K954986 | 000 |