510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K031834Substantially Equivalent

Xpect Giardia/cryptosporidium Lateral Flow Assay

Remel Inc, Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031834 is the FDA 510(k) clearance record for XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY, a class II device, cleared for Remel, Inc. on under FDA product code MHI (Giardia Spp.). FDA records list 107 510(k) clearances for Remel, Inc., from to . As of , FDA records show one recall naming K031834.

Clearance record

Decision date
Received
(150 days to decision)
Product code
MHI Giardia Spp.
Regulation
21 CFR 866.3220
Device class
Class II
Review panel
Microbiology
Applicant
Remel, Inc. 12076 Santa Fe Dr., Lenexa KS
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MHI

Trailing 12 months

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

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