510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141341Substantially Equivalent

Cl Detect Rapid Test

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

K141341 is the FDA 510(k) clearance record for CL DETECT RAPID TEST, a class I device, cleared for InBios International, Inc. on under FDA product code PIT (Leishmania Spp. Antigen Detection Assay). FDA's definition for product code PIT reads: "An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection". FDA records list 7 510(k) clearances for InBios International, Inc., from to . As of , FDA records show no recalls naming K141341.

Clearance record

Decision date
Received
(177 days to decision)
Product code
PIT Leishmania Spp. Antigen Detection Assay
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Applicant
InBios International, Inc. 562 1st Ave. S, Suite 600, Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code PIT

Trailing 12 months

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

FDA records show no clearances under product code PIT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PIT, 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