STC DIAGNOSTICS LSD MICRO-PLATE EIA

Radioimmunoassay, Lsd (125-i)

SOLARCARE TECHNOLOGIES CORP,INC.

The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Stc Diagnostics Lsd Micro-plate Eia.

Pre-market Notification Details

Device IDK954073
510k NumberK954073
Device Name:STC DIAGNOSTICS LSD MICRO-PLATE EIA
ClassificationRadioimmunoassay, Lsd (125-i)
Applicant SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem,  PA  18018 -1799
ContactR. Sam Niedbala
CorrespondentR. Sam Niedbala
SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem,  PA  18018 -1799
Product CodeDLB  
CFR Regulation Number862.3580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-30
Decision Date1995-11-29

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