510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171753Substantially Equivalent

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16

Leica Biosystems Newcastle Ltd., Newcastle Upon Tyne, GB / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K171753 is the FDA 510(k) clearance record for BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16, a class II device, cleared for Leica Biosystems Newcastle, Limited on under FDA product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor). FDA records list 6 510(k) clearances for Leica Biosystems Newcastle, Limited, from to . As of , FDA records show no recalls naming K171753.

Clearance record

Decision date
Received
(39 days to decision)
Product code
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Leica Biosystems Newcastle, Limited Balliol Business Park W., Newcastle Upon Tyne, GB
510(k) summary
Statement
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