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

Analyzer, Chromosome, Automated

21 CFR 864.5260 / Hematology
FDA source (opens on fda.gov)

LNJ is the FDA product code for Analyzer, Chromosome, Automated, a class II device type, regulated under 21 CFR 864.5260. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LNJ
Device name
Analyzer, Chromosome, Automated
Regulation
21 CFR 864.5260
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
11
Ingested recalls
0

Clearances, product code LNJ

By decision year
11 clearances under product code LNJ with a decision year between 1985 and 2005, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LNJ by decision year
YearClearances
19852
19861
19872
19902
19911
19951
20011
20051

Applicants with the most clearances

Product code LNJ
Applicants holding the most 510(k) clearances under product code LNJ
ApplicantClearances
Applied Spectral Imaging, Ltd.2
Amcor Electronics, Ltd.1
Amoco Technology Co.1
Applied Imaging Corp.1
Image Recognition Systems, Ltd.1
Metasystems GmbH1
Nikon, Inc.1
Perceptive Systems, Inc.1
Potomac Medical System1
W-Technology1

Companies listing this code with FDA

Companies whose registered establishments list this code