PCP DIRECT RIA KIT (I-125)

Radioimmunoassay, Phencyclidine

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Pcp Direct Ria Kit (i-125).

Pre-market Notification Details

Device IDK913864
510k NumberK913864
Device Name:PCP DIRECT RIA KIT (I-125)
ClassificationRadioimmunoassay, Phencyclidine
Applicant Immunalysis Corporation 1707 GARDENA AVE. Glendale,  CA  91204
ContactJames R Soares
CorrespondentJames R Soares
Immunalysis Corporation 1707 GARDENA AVE. Glendale,  CA  91204
Product CodeLCL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-27
Decision Date1991-10-11

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