RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY

Antisera, Fluorescent, Adenovirus 1-33

LIGHT DIAGNOSTICS

The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Resp. Panel 1 Indirect Immunofluorescence Assay.

Pre-market Notification Details

Device IDK922801
510k NumberK922801
Device Name:RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
ClassificationAntisera, Fluorescent, Adenovirus 1-33
Applicant LIGHT DIAGNOSTICS 27520 ENTERPRISE CIRCLE WEST Temecula,  CA  92390
ContactDale Dembrow
CorrespondentDale Dembrow
LIGHT DIAGNOSTICS 27520 ENTERPRISE CIRCLE WEST Temecula,  CA  92390
Product CodeGNY  
CFR Regulation Number866.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-10
Decision Date1993-01-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08436037122651 K922801 000
08436037123078 K922801 000
04053252789168 K922801 000
04053252284311 K922801 000
04053252286575 K922801 000

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