510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122766Substantially Equivalent

Thermo Scientific Qms Everolimus Assay

Microgenics Corporation, Fremont Blvd. CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122766 is the FDA 510(k) clearance record for THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY, a class II device, cleared for Microgenics Corp. on under FDA product code OUF (Everolimus Immunoassay). FDA's definition for product code OUF reads: "To quantify everolimus in whole blood". FDA records list 128 510(k) clearances for Microgenics Corp., from to . As of , FDA records show one recall naming K122766.

Clearance record

Decision date
Received
(344 days to decision)
Product code
OUF Everolimus Immunoassay
Regulation
21 CFR 862.3840
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Microgenics Corp. 46360 Fremont Blvd., Fremont Blvd. CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUF

Trailing 12 months

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

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