510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193115Substantially Equivalent

EUROIMMUN Anti-BP230-CF ELISA (IgG)

Euroimmun US Inc., Mountain Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K193115 is the FDA 510(k) clearance record for EUROIMMUN Anti-BP230-CF ELISA (IgG), a class II device, cleared for Euroimmun Us, Inc. on under FDA product code OEG (Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230). FDA's definition for product code OEG reads: "The device is intended as an aid in the diagnosis of bullous pemphigoid". FDA records list 37 510(k) clearances for Euroimmun Us, Inc., from to . As of , FDA records show no recalls naming K193115.

Clearance record

Decision date
Received
(310 days to decision)
Product code
OEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Euroimmun Us, Inc. 1 Bloomfield Ave., Mountain Lakes NJ
510(k) summary
Statement
Third party review
No

Clearances, product code OEG

Trailing 12 months

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

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