LABELED HUMAN CHORIONIC GONADOTROPHIN

Visual, Pregnancy Hcg, Prescription Use

PCL-RIA, INC.

The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Labeled Human Chorionic Gonadotrophin.

Pre-market Notification Details

Device IDK790876
510k NumberK790876
Device Name:LABELED HUMAN CHORIONIC GONADOTROPHIN
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-05-07
Decision Date1979-07-17

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