510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161947Substantially Equivalent

Chagas Detect Plus Rapid Test

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

K161947 is the FDA 510(k) clearance record for Chagas Detect Plus Rapid Test, a class I device, cleared for InBios International, Inc. on under FDA product code MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi). FDA records list 7 510(k) clearances for InBios International, Inc., from to . As of , FDA records show no recalls naming K161947.

Clearance record

Decision date
Received
(155 days to decision)
Product code
MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
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 MIU

Trailing 12 months

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

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