510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023483Substantially Equivalent

Kalazar Detect

Inbios Intl., Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023483 is the FDA 510(k) clearance record for KALAZAR DETECT, a class I device, cleared for Inbios Intl., Inc. on under FDA product code LOO (Reagent, Leishmanii Serological). FDA records list 6 510(k) clearances for Inbios Intl., Inc., from to . As of , FDA records show no recalls naming K023483.

Clearance record

Decision date
Received
(201 days to decision)
Product code
LOO Reagent, Leishmanii Serological
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Applicant
Inbios Intl., Inc. 562 1st Ave. S, Suite 600, Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code LOO

Trailing 12 months

FDA records hold no clearances under product code LOO in the trailing twelve months.

FDA records show no clearances under product code LOO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260