510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132195Substantially Equivalent

Euroimmun Anti-Pla2r Elisa (Igg)

Euroimmun US Inc., Morris Plains NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132195 is the FDA 510(k) clearance record for EUROIMMUN ANTI-PLA2R ELISA (IGG), a class II device, cleared for Euroimmun Us, Inc. on under FDA product code PGV (Anti-Phospholipase A2 Receptor). FDA's definition for product code PGV reads: "The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in...". FDA records list 37 510(k) clearances for Euroimmun Us, Inc., from to . As of , FDA records show no recalls naming K132195.

Clearance record

Decision date
Received
(347 days to decision)
Product code
PGV Anti-Phospholipase A2 Receptor
Regulation
21 CFR 866.5780
Device class
Class II
Review panel
Microbiology
Applicant
Euroimmun Us, Inc. 1100 The American Rd., Morris Plains NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGV

Trailing 12 months

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

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