510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013148Substantially Equivalent

Biogenex Monoclonal Anti-Estrogen Receptor(clone Er88)

Biogenex Laboratories, Inc., San Ramon CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013148 is the FDA 510(k) clearance record for BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88), a class II device, cleared for Biogenex Laboratories on under FDA product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor). FDA records list 12 510(k) clearances for Biogenex Laboratories, from to . As of , FDA records show no recalls naming K013148.

Clearance record

Decision date
Received
(161 days to decision)
Product code
MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Biogenex Laboratories 4600 Norris Canyon Rd., San Ramon CA
510(k) summary
Summary
Third party review
No

Clearances, product code MYA

Trailing 12 months

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

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