Cleared Traditional

KALAZAR DETECT

K023483 · Inbios Intl., Inc. · Microbiology
May 2003
Decision
201d
Days
Class 1
Risk

About This 510(k) Submission

K023483 is an FDA 510(k) clearance for the KALAZAR DETECT, a Reagent, Leishmanii Serological (Class I — General Controls, product code LOO), submitted by Inbios Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on May 6, 2003, 201 days after receiving the submission on October 17, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3870.

Submission Details

510(k) Number K023483 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2002
Decision Date May 06, 2003
Days to Decision 201 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LOO — Reagent, Leishmanii Serological
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3870