HDL PRECIPITANT REAGENT SET

Colorimetric Method, Lipoproteins

MEDICAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Hdl Precipitant Reagent Set.

Pre-market Notification Details

Device IDK841056
510k NumberK841056
Device Name:HDL PRECIPITANT REAGENT SET
ClassificationColorimetric Method, Lipoproteins
Applicant MEDICAL SPECIALTIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHM  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-12
Decision Date1984-05-01

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