DIGOXIN RADIOIMMUNOASSAY KIT

Radioimmunoassay, Digoxin (125-i)

TECHNIA DIAGNOSTICS LTD.

The following data is part of a premarket notification filed by Technia Diagnostics Ltd. with the FDA for Digoxin Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK801202
510k NumberK801202
Device Name:DIGOXIN RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Digoxin (125-i)
Applicant TECHNIA DIAGNOSTICS LTD. 803 N. Front St. Suite 3 McHenry,  IL  60050
Product CodeLCS  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-19
Decision Date1980-06-20

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