510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092399Substantially Equivalent

Anti-Mutated Citrullinated Vimentin Eia

Orgentec Diagnostika GmbH, East Stroudsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092399 is the FDA 510(k) clearance record for ANTI-MUTATED CITRULLINATED VIMENTIN EIA, a class II device, cleared for Orgentec Diagnostika GmbH on under FDA product code OQZ (Anti-Mutated Citrullinated Vimentin Igg). FDA's definition for product code OQZ reads: "For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma". FDA records list 3 510(k) clearances for Orgentec Diagnostika GmbH, from to . As of , FDA records show no recalls naming K092399.

Clearance record

Decision date
Received
(329 days to decision)
Product code
OQZ Anti-Mutated Citrullinated Vimentin Igg
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Orgentec Diagnostika GmbH 150 Cherry Ln. Rd., East Stroudsburg PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQZ

Trailing 12 months

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

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