QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.

Radioimmunoassay, Theophylline

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quanticoat 125 I-theophylline Radioimm..

Pre-market Notification Details

Device IDK821862
510k NumberK821862
Device Name:QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
ClassificationRadioimmunoassay, Theophylline
Applicant KALLESTAD LABORATORIES, INC. 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 Received1982-06-24
Decision Date1982-07-06

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