MUREX RUB-EX

Latex Agglutination Assay, Rubella

MUREX DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Murex Diagnostics, Inc. with the FDA for Murex Rub-ex.

Pre-market Notification Details

Device IDK954920
510k NumberK954920
Device Name:MUREX RUB-EX
ClassificationLatex Agglutination Assay, Rubella
Applicant MUREX DIAGNOSTICS, INC. 3075 NORTHWOODS CIR. Norcross,  GA  30071 -1542
ContactRobert K Shockley
CorrespondentRobert K Shockley
MUREX DIAGNOSTICS, INC. 3075 NORTHWOODS CIR. Norcross,  GA  30071 -1542
Product CodeLQN  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-26
Decision Date1996-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613647001240 K954920 000
00613647001233 K954920 000
08426950590583 K954920 000
08426950590576 K954920 000
00006136471240 K954920 000
00006136471233 K954920 000

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