FDA.reportPublic FDA data

510(k) K883599

Device
LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)
Applicant
INNOVATIVE MEDICAL SYSTEMS, INC.
510(k) number
K883599
Product code
IEO  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-02
Date received
1988-08-23
Regulation
864.3875
Classification name
Processor, Tissue, Automated
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH CATARIOUS
Address
55 Steamwhistle Dr. Ivyland PA US 18974 18974

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IEO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924590MICROWAVE AUTOMATED TISSUE PROCESSORInnovative Medical Systems, Inc.1992-12-29
K881165SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSORSakura Finetek U.S.A., Inc.1988-07-01
K853938LX 300 TISSUE PROCESSORInnovative Medical Systems, Inc.1985-10-10
K851054LX120 TISSUE PROCESSORInnovative Medical Systems, Inc.1985-05-15
K843506LKB 2189 ULTROPROCESSORLkb Instruments, Inc.1984-11-30
K834599AUTOTECHNICON V TISSUE PROCESS SYSTechnicon Instruments Corp.1984-02-04
K831313TISSUE-TEK V.I.P. 100/200Miles Laboratories, Inc.1983-07-28
K801427TISSUE-TEK III MINI-RAPID PROCESSORMiles Laboratories, Inc.1980-07-28
K801513TISSUE PROCESSING SYSTEMInnovative Medical Systems, Inc.1980-07-28
K771308TISSUE-TEK III V.I.P.Miles Laboratories, Inc.1977-08-22
K761062HISTO-TEK W/ AUTOMATIC COVERSLIPPERMiles Laboratories, Inc.1977-03-07

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

FDA Review#

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