HAEMOPHILUS TEST MEDIUM (AGAR)

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Haemophilus Test Medium (agar).

Pre-market Notification Details

Device IDK892928
510k NumberK892928
Device Name:HAEMOPHILUS TEST MEDIUM (AGAR)
ClassificationCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactBrenda Teply
CorrespondentBrenda Teply
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeJSO  
CFR Regulation Number866.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-21
Decision Date1989-06-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838004476 K892928 000
00848838001932 K892928 000

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