HUMAN GROWTH HORMONE-RADIOIMM. KIT

Radioimmunoassay, Human Growth Hormone

IMMUNO NUCLEAR CORP.

The following data is part of a premarket notification filed by Immuno Nuclear Corp. with the FDA for Human Growth Hormone-radioimm. Kit.

Pre-market Notification Details

Device IDK803280
510k NumberK803280
Device Name:HUMAN GROWTH HORMONE-RADIOIMM. KIT
ClassificationRadioimmunoassay, Human Growth Hormone
Applicant IMMUNO NUCLEAR CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFL  
CFR Regulation Number862.1370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-29
Decision Date1981-01-16

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