REMEL STAPH LATEX KIT

Kit, Screening, Staphylococcus Aureus

REMEL, L.P.

The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Remel Staph Latex Kit.

Pre-market Notification Details

Device IDK964315
510k NumberK964315
Device Name:REMEL STAPH LATEX KIT
ClassificationKit, Screening, Staphylococcus Aureus
Applicant REMEL, L.P. P.O. BOX 16276 Augusta,  GA  30919 -2276
ContactDavid A Wall
CorrespondentDavid A Wall
REMEL, L.P. P.O. BOX 16276 Augusta,  GA  30919 -2276
Product CodeJWX  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-29
Decision Date1997-02-07

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