510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050063Substantially Equivalent

Prostate-63 Cancer Diagnostic Test

Asymmetrx, Amston CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050063 is the FDA 510(k) clearance record for PROSTATE-63 CANCER DIAGNOSTIC TEST, a class I device, cleared for Asymmetrx on under FDA product code NTR (Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells). FDA's definition for product code NTR reads: "MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR...". FDA records list one 510(k) clearance for Asymmetrx. As of , FDA records show no recalls naming K050063.

Clearance record

Decision date
Received
(29 days to decision)
Product code
NTR Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
Regulation
21 CFR 864.1860
Device class
Class I
Review panel
Hematology
Applicant
Asymmetrx 117 Senate Brook Dr., Amston CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTR

Trailing 12 months

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

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