510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060462Substantially Equivalent

Neomarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone Sp2)

Lab Vision Corp., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060462 is the FDA 510(k) clearance record for NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2), a class II device, cleared for Lab Vision Corp. on under FDA product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor). FDA records list 2 510(k) clearances for Lab Vision Corp., from to . As of , FDA records show no recalls naming K060462.

Clearance record

Decision date
Received
(61 days to decision)
Product code
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Lab Vision Corp. 47777 Warm Springs Blvd., Fremont 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