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 |