IMMO PHASE DIRECT PROGESTERONE RADIO-

Radioimmunoassay, Progesterone

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Immo Phase Direct Progesterone Radio-.

Pre-market Notification Details

Device IDK830880
510k NumberK830880
Device Name:IMMO PHASE DIRECT PROGESTERONE RADIO-
ClassificationRadioimmunoassay, Progesterone
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-18
Decision Date1983-04-18

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