ORAL THC-CANNABINOIDS DIRECT RIA KIT

Radioimmunoassay, Cannabinoid(s)

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Oral Thc-cannabinoids Direct Ria Kit.

Pre-market Notification Details

Device IDK843534
510k NumberK843534
Device Name:ORAL THC-CANNABINOIDS DIRECT RIA KIT
ClassificationRadioimmunoassay, Cannabinoid(s)
Applicant Immunalysis Corporation 1707 GARDENA AVE. Glendale,  CA  91204
ContactJames R Soares
CorrespondentJames R Soares
Immunalysis Corporation 1707 GARDENA AVE. Glendale,  CA  91204
Product CodeLAT  
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-07
Decision Date1984-10-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.