NATAL-TEC HPL

Radioimmunoassay, Human Placental Lactogen

ARMKEL, LLC.

The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Natal-tec Hpl.

Pre-market Notification Details

Device IDK811370
510k NumberK811370
Device Name:NATAL-TEC HPL
ClassificationRadioimmunoassay, Human Placental Lactogen
Applicant ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJMF  
CFR Regulation Number862.1585 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-14
Decision Date1981-05-29

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