THEOPHYLLINE TEST KIT REF. #A874799

Radioimmunoassay, Theophylline

PHOTEC DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for Theophylline Test Kit Ref. #a874799.

Pre-market Notification Details

Device IDK880291
510k NumberK880291
Device Name:THEOPHYLLINE TEST KIT REF. #A874799
ClassificationRadioimmunoassay, Theophylline
Applicant PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls,  NJ  07424
ContactRobert P Henry
CorrespondentRobert P Henry
PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls,  NJ  07424
Product CodeLCA  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-25
Decision Date1988-03-24

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