GC BASE W/ 1% GCHI

Culture Media, For Isolation Of Pathogenic Neisseria

REMEL, L.P.

The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Gc Base W/ 1% Gchi.

Pre-market Notification Details

Device IDK954986
510k NumberK954986
Device Name:GC BASE W/ 1% GCHI
ClassificationCulture Media, For Isolation Of Pathogenic Neisseria
Applicant REMEL, L.P. 12076 SANTA FE DR. Lenexa,  KS  66215 -3594
ContactMary Ann Silvius
CorrespondentMary Ann Silvius
REMEL, L.P. 12076 SANTA FE DR. Lenexa,  KS  66215 -3594
Product CodeJTY  
CFR Regulation Number866.2410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-31
Decision Date1996-02-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838004469 K954986 000
00848838001796 K954986 000

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