KALAZAR DETECT


Device Classification Name

reagent, leishmanii serological

510(k) Number K023483
Device Name KALAZAR DETECT
Original Applicant
INBIOS INTL., INC.
562 1st. ave. south, suite 600
seattle, 
WA 
98104

Original Contact estela i raychaudhuri
Regulation Number 866.3870
Classification Product Code
LOO  
Date Received 10/17/2002
Decision Date 05/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No