510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181012Substantially Equivalent

BUHLMANN fCAL ELISA

Buhlmann Laboratories AG, Schonenbuch, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181012 is the FDA 510(k) clearance record for BUHLMANN fCAL ELISA, a class II device, cleared for Buhlmann Laboratories AG on under FDA product code NXO (Calprotectin, Fecal). FDA's definition for product code NXO reads: "The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's...". FDA records list 5 510(k) clearances for Buhlmann Laboratories AG, from to . As of , FDA records show no recalls naming K181012.

Clearance record

Decision date
Received
(48 days to decision)
Product code
NXO Calprotectin, Fecal
Regulation
21 CFR 866.5180
Device class
Class II
Review panel
Immunology
Applicant
Buhlmann Laboratories AG Baselstrasse 55, Schonenbuch, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXO

Trailing 12 months

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

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