510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012960Substantially Equivalent

Biogenex Monoclonal Anti-Progesterone Receptor

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

K012960 is the FDA 510(k) clearance record for BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR, a class II device, cleared for Biogenex Laboratories on under FDA product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor). FDA records list 12 510(k) clearances for Biogenex Laboratories, from to . As of , FDA records show no recalls naming K012960.

Clearance record

Decision date
Received
(185 days to decision)
Product code
MXZ Immunohistochemistry Assay, Antibody, Progesterone 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 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