IGM RF EIA

System, Test, Rheumatoid Factor

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Igm Rf Eia.

Pre-market Notification Details

Device IDK942908
510k NumberK942908
Device Name:IGM RF EIA
ClassificationSystem, Test, Rheumatoid Factor
Applicant SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis,  MO  63103
ContactJoseph Bohn
CorrespondentJoseph Bohn
SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis,  MO  63103
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-21
Decision Date1995-01-20

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