510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K170005Substantially Equivalent

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)

Agilent Technologies Denmark ApS, Golstrup, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170005 is the FDA 510(k) clearance record for FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis), a class II device, cleared for Dako Denmark A/S on under FDA product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor). FDA records list 2 510(k) clearances for Agilent Technologies Denmark ApS. As of , FDA records show no recalls naming K170005.

Clearance record

Decision date
Received
(352 days to decision)
Product code
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Dako Denmark A/S Produktionsvej 42, Golstrup, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXZ

Trailing 12 months

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

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