510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031059Substantially Equivalent

IVD Cryptosporidium Antigen Detection Assay, Model Cp-96

IVD Research, LLC., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031059 is the FDA 510(k) clearance record for IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96, a class II device, cleared for Ivd Research, Inc. on under FDA product code MHJ (Cryptosporidium Spp.). FDA records list 5 510(k) clearances for Ivd Research, Inc., from to . As of , FDA records show no recalls naming K031059.

Clearance record

Decision date
Received
(104 days to decision)
Product code
MHJ Cryptosporidium Spp.
Regulation
21 CFR 866.3220
Device class
Class II
Review panel
Microbiology
Applicant
Ivd Research, Inc. 5909 Sea Lion Pl., Suite D, Carlsbad CA
510(k) summary
Summary PDF
Third party review
Yes

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