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

Immunohistochemistry Assay, Antibody, Progesterone Receptor

21 CFR 864.1860 / Hematology
FDA source (opens on fda.gov)

MXZ is the FDA product code for Immunohistochemistry Assay, Antibody, Progesterone Receptor, a class II device type, regulated under 21 CFR 864.1860. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
MXZ
Device name
Immunohistochemistry Assay, Antibody, Progesterone Receptor
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
3

Clearances, product code MXZ

By decision year
13 clearances under product code MXZ with a decision year between 1999 and 2020, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MXZ by decision year
YearClearances
19991
20022
20051
20061
20071
20111
20131
20161
20172
20181
20201

Applicants with the most clearances

Product code MXZ
Applicants holding the most 510(k) clearances under product code MXZ
ApplicantClearances
Agilent Technologies, Inc.3
Leica Biosystems Newcastle Ltd.3
Biogenex Laboratories, Inc.1
Dako Corp.1
Agilent Technologies Denmark ApS1
Lab Vision Corp.1
Ventana Medical Systems Inc1
Ventana Medical Sytems, Inc.1
Vision Biosystems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code