CEDIA DAU LSD ASSAY

Radioimmunoassay, Lsd (125-i)

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Lsd Assay.

Pre-market Notification Details

Device IDK955814
510k NumberK955814
Device Name:CEDIA DAU LSD ASSAY
ClassificationRadioimmunoassay, Lsd (125-i)
Applicant MICROGENICS CORP. 2380 A BISSO LN. Concord,  CA  94520
ContactMary Koning
CorrespondentMary Koning
MICROGENICS CORP. 2380 A BISSO LN. Concord,  CA  94520
Product CodeDLB  
CFR Regulation Number862.3580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-26
Decision Date1996-02-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883005679 K955814 000

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