ANGIOTENSIN CONVERTING ENZYME

Radioimmunoassay, Angiotensin I And Renin

IMMUNO-DIAGNOSTIC LABORATORIES

The following data is part of a premarket notification filed by Immuno-diagnostic Laboratories with the FDA for Angiotensin Converting Enzyme.

Pre-market Notification Details

Device IDK833777
510k NumberK833777
Device Name:ANGIOTENSIN CONVERTING ENZYME
ClassificationRadioimmunoassay, Angiotensin I And Renin
Applicant IMMUNO-DIAGNOSTIC LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIB  
CFR Regulation Number862.1085 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-27
Decision Date1984-01-30

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