510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820336Substantially Equivalent

Dako Pap Kit K509

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

K820336 is the FDA 510(k) clearance record for DAKO PAP KIT K509, a class I device, cleared for Dako Corp. on under FDA product code LIJ (Peroxidase Anti-Peroxidase Immunohistochemical Stain). FDA records list 23 510(k) clearances for Dako Corp., from to . As of , FDA records show no recalls naming K820336.

Clearance record

Decision date
Received
(155 days to decision)
Product code
LIJ Peroxidase Anti-Peroxidase Immunohistochemical Stain
Regulation
21 CFR 864.4400
Device class
Class I
Review panel
Pathology
Applicant
Dako Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LIJ

Trailing 12 months

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

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