TOUCH TEAR IGE MICROASSAY KIT

Ige, Antigen, Antiserum, Control

TOUCH SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Touch Scientific, Inc. with the FDA for Touch Tear Ige Microassay Kit.

Pre-market Notification Details

Device IDK991316
510k NumberK991316
Device Name:TOUCH TEAR IGE MICROASSAY KIT
ClassificationIge, Antigen, Antiserum, Control
Applicant TOUCH SCIENTIFIC, INC. 3209 GRESHAM LAKE RD. SUITE 112 Raleigh,  NC  27615
ContactAlan J Touch
CorrespondentAlan J Touch
TOUCH SCIENTIFIC, INC. 3209 GRESHAM LAKE RD. SUITE 112 Raleigh,  NC  27615
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-19
Decision Date1999-08-09

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