BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.

Radioimmunoassay, Theophylline

BIOCLINICAL CORP.

The following data is part of a premarket notification filed by Bioclinical Corp. with the FDA for Bio-mag Theophylline (125i) Radioimmun..

Pre-market Notification Details

Device IDK821347
510k NumberK821347
Device Name:BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.
ClassificationRadioimmunoassay, Theophylline
Applicant BIOCLINICAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLCA  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-05
Decision Date1982-05-28

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