510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880341Substantially Equivalent

N-Immunoglobulin Light Chain Kit

Behring Diagnostics, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880341 is the FDA 510(k) clearance record for N-IMMUNOGLOBULIN LIGHT CHAIN KIT, a class II device, cleared for Behring Diagnostics, Inc. on under FDA product code DFH (Kappa, Antigen, Antiserum, Control). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K880341.

Clearance record

Decision date
Received
(22 days to decision)
Product code
DFH Kappa, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Behring Diagnostics, Inc. 17 Chubb Way, Somerville NJ
Third party review
No

Clearances, product code DFH

Trailing 12 months
1 clearance under product code DFH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DFH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260