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510(k) K811697

Device
GUAMSTAINER
Applicant
TOMTEC
510(k) number
K811697
Product code
KPA  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-02
Date received
1981-06-16
Regulation
864.3800
Classification name
Slide Stainer, Automated
Medical specialty
Pathology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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 KPA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933996PROFIBLOTTecan U.S., Ltd.1994-01-28
K884258VERSABLOTAmerican Bionetics, Inc.1988-12-14
K881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERWescor, Inc.1988-05-13
K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.1988-04-27
K874887WESBLOT PROCESSORAmerican Bionetics, Inc.1988-03-24
K874897SAKURA DRS-60 AUTOMATIC SLIDE STAINERSakura Finetek U.S.A., Inc.1988-01-05
K872916HISTOMATIC SLIDE STAINER, CODE-ON VERSIONFisher Scientific Co., LLC1987-09-14
K853210MST-1050-II X-RAY UNITRadiological Engineering, Inc.1985-10-10
K850333PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERSShaban Mfg. Co.1985-02-27
K850157CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERSShaban Mfg. Co.1985-02-27
K842077MIDAS II AUTOMATIC STAINERInnovative Medical Systems, Inc.1984-07-27
K833295WESCOR 7100 AEROSPRAY SLIDE STAINERWescor, Inc.1983-10-31
K832994MIDAS 6000 AUTOMATIC STAINERInnovative Medical Systems, Inc.1983-09-29
K821830MI DAS 1000 AUTOMATIC SLIDE STAINERInnovative Medical Systems, Inc.1982-07-22
K781598TECHNICON AUTOSLIDE STAINING/PROCESSINGTechnicon Instruments Corp.1978-10-17

Legacy Summary#

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FDA Review#

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