PHASE II B-12/FOLATE KIT

Radioassay, Vitamin B12

MEDICAL & SCIENTIFIC DESIGNS, INC.

The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Phase Ii B-12/folate Kit.

Pre-market Notification Details

Device IDK853224
510k NumberK853224
Device Name:PHASE II B-12/FOLATE KIT
ClassificationRadioassay, Vitamin B12
Applicant MEDICAL & SCIENTIFIC DESIGNS, INC. 273 WEYMOUTH ST. Rockland,  MA  02370
ContactKenneth L Hoffman
CorrespondentKenneth L Hoffman
MEDICAL & SCIENTIFIC DESIGNS, INC. 273 WEYMOUTH ST. Rockland,  MA  02370
Product CodeCDD  
CFR Regulation Number862.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-01
Decision Date1985-10-03

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