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

Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

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

NQN is the FDA product code for Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity, a class II device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention". As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
NQN
Device name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
FDA definition
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
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
No
Ingested clearances
15
Ingested recalls
4

Clearances, product code NQN

By decision year
15 clearances under product code NQN with a decision year between 2004 and 2015, 2013 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NQN by decision year
YearClearances
20042
20051
20062
20071
20081
20101
20122
20133
20141
20151

Applicants with the most clearances

Product code NQN
Applicants holding the most 510(k) clearances under product code NQN
ApplicantClearances
Ventana Medical Systems Inc6
Becton Dickinson & Co4
Leica Biosystems Imaging, Inc.1
Applied Imaging Corp.1
Applied Spectral Imaging, Ltd.1
Bioimagene, Inc.1
Cell Analysis, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code