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Neurology
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Obstetrical and Gynecological
Review Panel
Ophthalmic
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Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart C—Cell And Tissue Culture Products
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
IEO
Processor, Tissue, Automated
1
Product Code
IFB
Cytocentrifuge
1
Product Code
IBJ
Light, Microscope
1
Product Code
IBK
Microscope, Fluorescence/U.V.
1
Product Code
IBL
Microscope, Inverted Stage, Tissue Culture
1
Product Code
IBM
Microscope, Phase Contrast
1
Product Code
IDL
Microtome, Accessories
1
Product Code
IDM
Microtome, Ultra
1
Product Code
IDN
Microtome, Freezing Attachment
1
Product Code
IDO
Microtome, Rotary
1
Product Code
IDP
Microtome, Cryostat
1
Product Code
IDQ
Infiltrator
1
Product Code
IDR
Ovens, Paraffin
1
Product Code
IDS
Melting Pot, Paraffin
1
Product Code
IDT
Apparatus, Melting Point, Paraffin
1
Product Code
IDW
Dispensers, Paraffin
1
Product Code
IDX
Sieves, Tissue
1
Product Code
IDY
Bath, Flotation, Tissue
1
Product Code
IDZ
Cassettes, Tissue
1
Product Code
IEG
Table, Slide Warming
1
Product Code
IEH
Lamps, Slide Warming
1
Product Code
IHJ
Blender, Sputum
1
Product Code
KDT
Container, Specimen Mailer And Storage, Sterile
1
Product Code
KDW
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
1
Product Code
KDZ
Device, Decalcifier, Electrolytic
1
Product Code
KEG
Lamps, Microscope
1
Product Code
KEH
Micrometers, Microscope
1
Product Code
KEI
Condensers, Microscope
1
Product Code
KEJ
Stages, Microscope
1
Product Code
KER
Container, Embedding
1
Product Code
KES
Coverslips, Microscope Slide
1
Product Code
KET
Filters, Cell Collection, Tissue Processing
1
Product Code
KEW
Slides, Microscope
1
Product Code
KEY
Stainer, Tissue, Automated
1
Product Code
KFL
Microtome, Sliding
1
Product Code
KIM
Device For Sealing Microsections
1
Product Code
KIN
Slide Stainer, Contact Type
1
Product Code
KIO
Slide Stainer, Immersion Type
1
Product Code
KJG
Tube, Tissue Culture
1
Product Code
KPA
Slide Stainer, Automated
1
Product Code
K
93
3996
PROFIBLOT
1
Cleared 510(K)
K
88
4258
VERSABLOT
1
Cleared 510(K)
K
88
1592
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
1
Cleared 510(K)
K
88
0745
LX-100 SLIDE STAINER
1
Cleared 510(K)
K
87
4887
WESBLOT PROCESSOR
1
Cleared 510(K)
K
87
4897
SAKURA DRS-60 AUTOMATIC SLIDE STAINER
1
Cleared 510(K)
K
87
2916
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
1
Cleared 510(K)
K
85
3210
MST-1050-II X-RAY UNIT
1
Cleared 510(K)
K
85
0333
PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS
1
Cleared 510(K)
K
85
0157
CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS
1
Cleared 510(K)
K
84
2077
MIDAS II AUTOMATIC STAINER
1
Cleared 510(K)
K
83
3295
WESCOR 7100 AEROSPRAY SLIDE STAINER
1
Cleared 510(K)
K
83
2994
MIDAS 6000 AUTOMATIC STAINER
1
Cleared 510(K)
K
82
1830
MI DAS 1000 AUTOMATIC SLIDE STAINER
1
Cleared 510(K)
K
81
1697
GUAMSTAINER
1
Cleared 510(K)
K
78
1598
TECHNICON AUTOSLIDE STAINING/PROCESSING
1
Cleared 510(K)
K
78
0637
HEMATOLOGY SLIDE STAINER
1
Cleared 510(K)
K
78
0017
AUTO. SLIDE STAINER
1
Cleared 510(K)
K
77
1699
CARA-STAIN MODEL 3000
1
Cleared 510(K)
K
77
1559
HEMA-TEK II SLIDE STAINER
1
Cleared 510(K)
K
77
0076
BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK
1
Cleared 510(K)
LEC
Grinder, Tissue
1
Product Code
MJI
Specimen/Tissue, Identification Orientation
1
Product Code
NNK
Container, Specimen Mailer And Storage, Non-Sterile
1
Product Code
NNL
Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile
1
Product Code
PSY
Whole Slide Imaging System
2
Product Code
PZZ
Digital Pathology Display
2
Product Code
QKQ
Digital Pathology Image Viewing And Management Software
2
Product Code
QPN
Software Algorithm Device To Assist Users In Digital Pathology
2
Product Code
Subpart E—Immunology Laboratory Equipment and Reagents
CFR Sub-Part
Subpart E—Specimen Preparation Reagents
CFR Sub-Part
Subpart F—Automated and Semi-Automated Hematology Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Subpart G—Tumor Associated Antigen immunological Test Systems
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
CFR Sub-Part
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
PA
/
subpart-d—pathology-instrumentation-and-accessories
/
KPA
/
K821830
View Source
MI DAS 1000 AUTOMATIC SLIDE STAINER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K821830
510(k) Type
Traditional
Applicant
INNOVATIVE MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/22/1982
Days to Decision
30 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Miscellaneous
Subpart B—Biological Stains
Subpart C—Cell And Tissue Culture Products
Subpart D—Pathology Instrumentation and Accessories
IEO
Processor, Tissue, Automated
IFB
Cytocentrifuge
IBJ
Light, Microscope
IBK
Microscope, Fluorescence/U.V.
IBL
Microscope, Inverted Stage, Tissue Culture
IBM
Microscope, Phase Contrast
IDL
Microtome, Accessories
IDM
Microtome, Ultra
IDN
Microtome, Freezing Attachment
IDO
Microtome, Rotary
IDP
Microtome, Cryostat
IDQ
Infiltrator
IDR
Ovens, Paraffin
IDS
Melting Pot, Paraffin
IDT
Apparatus, Melting Point, Paraffin
IDW
Dispensers, Paraffin
IDX
Sieves, Tissue
IDY
Bath, Flotation, Tissue
IDZ
Cassettes, Tissue
IEG
Table, Slide Warming
IEH
Lamps, Slide Warming
IHJ
Blender, Sputum
KDT
Container, Specimen Mailer And Storage, Sterile
KDW
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
KDZ
Device, Decalcifier, Electrolytic
KEG
Lamps, Microscope
KEH
Micrometers, Microscope
KEI
Condensers, Microscope
KEJ
Stages, Microscope
KER
Container, Embedding
KES
Coverslips, Microscope Slide
KET
Filters, Cell Collection, Tissue Processing
KEW
Slides, Microscope
KEY
Stainer, Tissue, Automated
KFL
Microtome, Sliding
KIM
Device For Sealing Microsections
KIN
Slide Stainer, Contact Type
KIO
Slide Stainer, Immersion Type
KJG
Tube, Tissue Culture
KPA
Slide Stainer, Automated
K
93
3996
PROFIBLOT
K
88
4258
VERSABLOT
K
88
1592
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
K
88
0745
LX-100 SLIDE STAINER
K
87
4887
WESBLOT PROCESSOR
K
87
4897
SAKURA DRS-60 AUTOMATIC SLIDE STAINER
K
87
2916
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
K
85
3210
MST-1050-II X-RAY UNIT
K
85
0333
PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS
K
85
0157
CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS
K
84
2077
MIDAS II AUTOMATIC STAINER
K
83
3295
WESCOR 7100 AEROSPRAY SLIDE STAINER
K
83
2994
MIDAS 6000 AUTOMATIC STAINER
K
82
1830
MI DAS 1000 AUTOMATIC SLIDE STAINER
K
81
1697
GUAMSTAINER
K
78
1598
TECHNICON AUTOSLIDE STAINING/PROCESSING
K
78
0637
HEMATOLOGY SLIDE STAINER
K
78
0017
AUTO. SLIDE STAINER
K
77
1699
CARA-STAIN MODEL 3000
K
77
1559
HEMA-TEK II SLIDE STAINER
K
77
0076
BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK
LEC
Grinder, Tissue
MJI
Specimen/Tissue, Identification Orientation
NNK
Container, Specimen Mailer And Storage, Non-Sterile
NNL
Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile
PSY
Whole Slide Imaging System
PZZ
Digital Pathology Display
QKQ
Digital Pathology Image Viewing And Management Software
QPN
Software Algorithm Device To Assist Users In Digital Pathology
Subpart E—Immunology Laboratory Equipment and Reagents
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—Immunological Test Systems
Subpart G—Tumor Associated Antigen immunological Test Systems
Subpart H—Hematology Kits and Packages
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PA
/
subpart-d—pathology-instrumentation-and-accessories
/
KPA
/
K821830
View Source
MI DAS 1000 AUTOMATIC SLIDE STAINER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K821830
510(k) Type
Traditional
Applicant
INNOVATIVE MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/22/1982
Days to Decision
30 days