HUMAN CHORIONIC GONADOTROPIN (RIA)

Visual, Pregnancy Hcg, Prescription Use

NUCLEAR MEDICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Human Chorionic Gonadotropin (ria).

Pre-market Notification Details

Device IDK792197
510k NumberK792197
Device Name:HUMAN CHORIONIC GONADOTROPIN (RIA)
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant NUCLEAR MEDICAL LABORATORIES, 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 Received1979-11-01
Decision Date1979-12-06

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