D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN

Radioassay, Triiodothyronine Uptake

PHOTEC DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for D-chem(tm) T-uptake Test Kit For T-uptake Determin.

Pre-market Notification Details

Device IDK892224
510k NumberK892224
Device Name:D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
ClassificationRadioassay, Triiodothyronine Uptake
Applicant PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls,  NJ  07424
ContactBarry Mcdonald
CorrespondentBarry Mcdonald
PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls,  NJ  07424
Product CodeKHQ  
CFR Regulation Number862.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-03
Decision Date1989-06-16

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