LNJ · Class II · 21 CFR 864.5260

FDA Product Code LNJ: Analyzer, Chromosome, Automated

Leading manufacturers include Applied Spectral Imaging , Ltd., Potomac Medical System and Nikon, Inc..

11
Total
11
Cleared
129d
Avg days
1985
Since

FDA 510(k) Cleared Analyzer, Chromosome, Automated Devices (Product Code LNJ)

11 devices
1–11 of 11
Cleared Jun 27, 2005
FISHVIEW
K050236
Applied Spectral Imaging , Ltd.
Pathology · 147d
Cleared Sep 14, 2001
BANDVIEW SYSTEM
K012103
Applied Spectral Imaging , Ltd.
Pathology · 71d
Cleared Feb 24, 1995
IKAROS
K940240
Metasystems GmbH
Pathology · 401d
Cleared Oct 31, 1991
ACLAIMS-IS
K912085
W-Technology
Pathology · 171d
Cleared Aug 20, 1990
GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.
K902311
Applied Imaging Corp.
Pathology · 89d
Cleared Feb 09, 1990
AKS II
K895095
Amoco Technology Co.
Pathology · 179d
Cleared Sep 01, 1987
KARYOTEC 100
K872755
Amcor Electronics, Ltd.
Pathology · 50d
Cleared Mar 16, 1987
CYTOSCAN
K864955
Image Recognition Systems , Ltd.
Pathology · 88d
Cleared Aug 04, 1986
PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
K861974
Perceptive Systems, Inc.
Pathology · 75d
Cleared Jul 12, 1985
NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS
K851508
Nikon, Inc.
Pathology · 88d
Cleared May 23, 1985
METACHROME
K851174
Potomac Medical System
Hematology · 59d

About Product Code LNJ - Regulatory Context