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

Microscope, Automated, Image Analysis, Operator Intervention

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

NOT is the FDA product code for Microscope, Automated, Image Analysis, Operator Intervention, 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 cell membrane intensity and pattern with operator intervention". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NOT
Device name
Microscope, Automated, Image Analysis, Operator Intervention
FDA definition
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern 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
13
Ingested recalls
2

Clearances, product code NOT

By decision year
13 clearances under product code NOT with a decision year between 2003 and 2026, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NOT by decision year
YearClearances
20031
20041
20051
20072
20092
20111
20122
20131
20141
20261

Applicants with the most clearances

Product code NOT
Applicants holding the most 510(k) clearances under product code NOT
ApplicantClearances
Ventana Medical Systems Inc4
Leica Biosystems Imaging, Inc.3
Bioimagene, Inc.2
Applied Imaging Corp.1
Chroma Vision Medical Systems, Inc.1
OptraSCAN Inc.1
Becton Dickinson & Co1

Companies listing this code with FDA

Companies whose registered establishments list this code