510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160922Substantially Equivalent

FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

Agilent Technologies, Inc., Carpinteria CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160922 is the FDA 510(k) clearance record for FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link), a class II device, cleared for Dako North America, Inc. on under FDA product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor). FDA records list 51 510(k) clearances for Agilent Technologies, Inc., from to . As of , FDA records show no recalls naming K160922.

Clearance record

Decision date
Received
(29 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 North America, Inc. 6392 Via Real, Carpinteria CA
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