510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031965Substantially Equivalent

Xpect Cryptosporidium Lateral Flow Assay, Model 2451020

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

K031965 is the FDA 510(k) clearance record for XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020, a class II device, cleared for Remel, Inc. on under FDA product code MHJ (Cryptosporidium Spp.). FDA records list 3 510(k) clearances for Remel, Inc., from to . As of , FDA records show one recall naming K031965.

Clearance record

Decision date
Received
(141 days to decision)
Product code
MHJ Cryptosporidium Spp.
Regulation
21 CFR 866.3220
Device class
Class II
Review panel
Microbiology
Applicant
Remel, Inc. 1400 Unity St. Northwest, Ramsey MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MHJ

Trailing 12 months

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

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