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

System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

21 CFR 866.4700 / Immunology
FDA source (opens on fda.gov)

NTH is the FDA product code for System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays, a class II device type, regulated under 21 CFR 866.4700. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NTH
Device name
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Regulation
21 CFR 866.4700
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code NTH

By decision year
8 clearances under product code NTH with a decision year between 2004 and 2014, 2005 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NTH by decision year
YearClearances
20041
20052
20081
20101
20111
20131
20141

Applicants with the most clearances

Product code NTH
Applicants holding the most 510(k) clearances under product code NTH
ApplicantClearances
Applied Spectral Imaging, Ltd.3
Applied Imaging Corp.2
Bioview1
Ikonisys, Inc.1
Vysis1

Companies listing this code with FDA

Companies whose registered establishments list this code