ACCESS RUBELLA IGG

Enzyme Linked Immunoabsorbent Assay, Rubella

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Rubella Igg.

Pre-market Notification Details

Device IDK954687
510k NumberK954687
Device Name:ACCESS RUBELLA IGG
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactCarole Stamp
CorrespondentCarole Stamp
BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-11
Decision Date1996-04-09
Summary:summary

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