MUELLER HINTON AGAR WITH 2% NACI

Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

REMEL, L.P.

The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Mueller Hinton Agar With 2% Naci.

Pre-market Notification Details

Device IDK960313
510k NumberK960313
Device Name:MUELLER HINTON AGAR WITH 2% NACI
ClassificationCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Applicant REMEL, L.P. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactMary Ann Silvius
CorrespondentMary Ann Silvius
REMEL, L.P. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeJTZ  
CFR Regulation Number866.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-22
Decision Date1996-03-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838002441 K960313 000
00848838012280 K960313 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.