510(k) K861974

Device: PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
Applicant: PERCEPTIVE SYSTEMS, INC.
510(k) number: K861974
Product code: LNJ
Decision: Substantially Equivalent (SESE)
Decision date: 1986-08-04
Date received: 1986-05-21
Regulation: 864.5260
Classification name: Analyzer, Chromosome, Automated
Medical specialty: Hematology
Review panel: Pathology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: RICHARD TOMPKINS
Address: 1301 Regents Park Dr. Houston TX US 77058 77058

FDA Registration Numbers#

9615060
9680625

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LNJ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K050236	FISHVIEW	Applied Spectral Imaging , Ltd.	2005-06-27
K012103	BANDVIEW SYSTEM	Applied Spectral Imaging , Ltd.	2001-09-14
K940240	IKAROS	Metasystems GmbH	1995-02-24
K912085	ACLAIMS-IS	W-Technology	1991-10-31
K902311	GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.	Applied Imaging Corp.	1990-08-20
K895095	AKS II	Amoco Technology Co.	1990-02-09
K872755	KARYOTEC 100	Amcor Electronics, Ltd.	1987-09-01
K864955	CYTOSCAN	Image Recognition Systems , Ltd.	1987-03-16
K851508	NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS	Nikon, Inc.	1985-07-12
K851174	METACHROME	Potomac Medical System	1985-05-23

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases