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510(k) K843506

Device
LKB 2189 ULTROPROCESSOR
Applicant
LKB INSTRUMENTS, INC.
510(k) number
K843506
Product code
IEO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-30
Date received
1984-09-06
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
ED ZIOR
Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K883599LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)Innovative Medical Systems, Inc.1988-09-02
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
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#

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FDA Review#

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