510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831904Substantially Equivalent

Rabbit Antiserum to Human Kappa Light

Dako Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831904 is the FDA 510(k) clearance record for RABBIT ANTISERUM TO HUMAN KAPPA LIGHT, a class II device, cleared for Dako Corp. on under FDA product code DEO (Kappa, Fitc, Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Dako Corp. As of , FDA records show no recalls naming K831904.

Clearance record

Decision date
Received
(35 days to decision)
Product code
DEO Kappa, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Dako Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DEO

Trailing 12 months

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

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