KALAZAR DETECT

Reagent, Leishmanii Serological

INBIOS INTL., INC.

The following data is part of a premarket notification filed by Inbios Intl., Inc. with the FDA for Kalazar Detect.

Pre-market Notification Details

Device IDK023483
510k NumberK023483
Device Name:KALAZAR DETECT
ClassificationReagent, Leishmanii Serological
Applicant INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle,  WA  98104
ContactEstela I Raychaudhuri
CorrespondentEstela I Raychaudhuri
INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle,  WA  98104
Product CodeLOO  
CFR Regulation Number866.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-17
Decision Date2003-05-06

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