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

Immunohistochemistry Antibody Assay, Estrogen Receptor

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

MYA is the FDA product code for Immunohistochemistry Antibody Assay, Estrogen Receptor, a class II device type, regulated under 21 CFR 864.1860. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
MYA
Device name
Immunohistochemistry Antibody Assay, Estrogen 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
12
Ingested recalls
3

Clearances, product code MYA

By decision year
12 clearances under product code MYA with a decision year between 1999 and 2018, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MYA by decision year
YearClearances
19991
20001
20022
20062
20091
20121
20131
20141
20171
20181

Applicants with the most clearances

Product code MYA
Applicants holding the most 510(k) clearances under product code MYA
ApplicantClearances
Agilent Technologies, Inc.2
Leica Biosystems Newcastle Ltd.2
Biogenex Laboratories, Inc.1
Chroma Vision Medical Systems, Inc.1
Dako Corp.1
Agilent Technologies Denmark ApS1
Lab Vision Corp.1
Ventana Medical Systems Inc1
Ventana, Inc.1
Vision Biosystems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code