HAEMOPHILUS IDENTIFICATION TEST KIT

Discs, Strips And Reagents, Microorganism Differentiation

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Haemophilus Identification Test Kit.

Pre-market Notification Details

Device IDK833963
510k NumberK833963
Device Name:HAEMOPHILUS IDENTIFICATION TEST KIT
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant REMEL CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-16
Decision Date1983-12-30

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