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510(k) K874207

Device
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
Applicant
INTL. REMOTE IMAGING SYSTEMS
510(k) number
K874207
Product code
IBJ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-01-05
Date received
1987-10-15
Regulation
864.3600
Classification name
Light, Microscope
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KASDEN, PHD
Address
9162 Eton Ave. Chatsworth CA US 91311 91311

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IBJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874750VIDEO ANALYZER 4000Scientific Imaging, Inc.1988-04-25
K874190CELL COUNTING GRID GRATICULEPortable Medical Laboratories, Inc.1988-01-05
K864049MCARTHUR MICROSCOPE, STANDARD METAL VERSIONPortable Medical Laboratories, Inc.1986-10-29
K854735MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.Portable Medical Laboratories, Inc.1985-12-10
K823040PATHOLOGY INSTRUMENTATION & ACCESSORIESIris Remote Imaging Systems1983-01-14
K8222072XC MICROSCOPEAmarel Precision Instruments, Inc.1982-08-05
K821865A O MICROSCOPE VIDEO SYSTEMWarner-Lambert Co.1982-07-14
K802818PULLEN POCKET SCOPEP.A. Research Corp.1981-04-17

Legacy Summary#

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FDA Review#

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