FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
GMB
Light, Wood'S, Fluorescence
1
Product Code
GTL
Phages, Staphylococcal Typing, All Types
1
Product Code
JRZ
Media, Culture, Amino Acid Assay
1
Product Code
JSA
Culture Media, Antibiotic Assay
1
Product Code
JSB
Culture Media, Vitamin Assay
1
Product Code
JSC
Culture Media, General Nutrient Broth
1
Product Code
JSD
Culture Media, Selective Broth
1
Product Code
JSE
Culture Media, Multiple Biochemical Test
1
Product Code
JSF
Culture Media, Single Biochemical Test
1
Product Code
JSG
Culture Media, Non-Selective And Non-Differential
1
Product Code
JSH
Culture Media, Non-Selective And Differential
1
Product Code
JSI
Culture Media, Selective And Differential
1
Product Code
JSJ
Culture Media, Selective And Non-Differential
1
Product Code
JSK
Supplement, Culture Media
1
Product Code
JSL
Culture Media, Anaerobic Transport
1
Product Code
JSM
Culture Media, Non-Propagating Transport
1
Product Code
JSN
Culture Media, Propagating Transport
1
Product Code
JSP
Kit, Anaerobic Identification
1
Product Code
JSR
Kit, Identification, Dermatophyte
1
Product Code
JSS
Kit, Identification, Enterobacteriaceae
1
Product Code
JST
Kit, Fastidious Organisms
1
Product Code
JSW
Kit, Identification, Glucose Nonfermenter
1
Product Code
JSX
Kit, Identification, Neisseria Gonorrhoeae
1
Product Code
JSY
Kit, Identification, Mycobacteria
1
Product Code
JSZ
Kit, Identification, Pseudomonas
1
Product Code
JTA
Monitor, Microbial Growth
1
Product Code
JTB
Device, Media Dispensing/Stacking
1
Product Code
JTC
Device, Microtiter Diluting/Dispensing
1
Product Code
K
92
4907
FILTERMATE UNIVERSAL HARVESTER
1
Cleared 510(K)
K
90
1808
MICROMATE 196 MODEL A961960
1
Cleared 510(K)
K
89
4645
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
1
Cleared 510(K)
K
89
2369
MULTI-PROBE HEAD PLUS
1
Cleared 510(K)
K
89
1765
GENETIC SYSTEMS PIPETTOR/DILUTOR
1
Cleared 510(K)
K
89
1766
GENETIC SYSTEMS MICROPLATE STRIP WASHER
1
Cleared 510(K)
K
89
1768
GENETIC SYSTEMS MICROPLATE WASHER
1
Cleared 510(K)
K
88
4695
WASHER 500 MICROELISA SYSTEM
1
Cleared 510(K)
K
88
4125
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
1
Cleared 510(K)
K
87
4598
DYNATECH MR 250 MANUAL MICROELISA READER
1
Cleared 510(K)
K
87
3542
MICROPLATE AUTO-WASHER (MOTORIZED STAGE)
1
Cleared 510(K)
K
87
1945
MICROLAB AT
1
Cleared 510(K)
K
86
3423
CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
1
Cleared 510(K)
K
86
3374
CODE-A-WELL SERIES 1-600, 1-625
1
Cleared 510(K)
K
86
2802
MULTI-CHANNEL MICROPIPETTES
1
Cleared 510(K)
K
86
2066
TITERTEK MICROPLATE WASHER S-12
1
Cleared 510(K)
K
86
0617
POLYPET
1
Cleared 510(K)
K
85
3920
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER
1
Cleared 510(K)
K
85
3380
SPR 2 AUTODILUTER
1
Cleared 510(K)
K
85
1020
MIC-CONCEPT INOCULATOR
1
Cleared 510(K)
K
85
1019
MIC-CONCEPT INOCULUM SEED TRAY
1
Cleared 510(K)
K
85
0908
TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA
1
Cleared 510(K)
K
85
0249
BIO-TEK AUTOMATED MICROPLATE WASHER EL402
1
Cleared 510(K)
K
85
0371
INTIWASH MANUAL MICROPLATE WASHER
1
Cleared 510(K)
K
84
4893
SLT 223 DISPENSER FOR MICROTITERPLATES
1
Cleared 510(K)
K
84
4891
SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES
1
Cleared 510(K)
K
84
4568
TITERTEK DULUTER/DISPENSER 78-640-00
1
Cleared 510(K)
K
84
4552
BIO-STAT III PLATE WASHER
1
Cleared 510(K)
K
84
4500
TITERTEK MICROPLATE WASHER 120
1
Cleared 510(K)
K
84
3272
T.I.M.E. DISPENSER
1
Cleared 510(K)
K
84
2848
CODE-A-WELL 350 MICROTITRATION STRIPS
1
Cleared 510(K)
K
83
1462
API UNISCEPT PLUS 140 INOCULATOR
1
Cleared 510(K)
K
83
2203
MULTI-TITER DISPENSER
1
Cleared 510(K)
K
83
1640
WASHER 6000 MICRO-C LISA SYSTEM
1
Cleared 510(K)
K
83
1644
PIPETTE 12 CHANNEL
1
Cleared 510(K)
K
83
1341
API UNISCEPT PLUS AUTOINOCULATOR
1
Cleared 510(K)
K
83
0059
MUELLER HINTON W/50% SHEEP BLOOD
1
Cleared 510(K)
K
82
3137
OCTAPETTES
1
Cleared 510(K)
K
82
3218
DISPOSABLE DISPENSE MANIFOLD
1
Cleared 510(K)
K
82
1961
96 WELL DISPENSER
1
Cleared 510(K)
K
82
0992
MICROPLATE WASHING DEVICE
1
Cleared 510(K)
K
82
0821
MIC-2000 PLUS, 96 CHANNEL DISPENSER
1
Cleared 510(K)
K
81
2860
IMMUNOASSAY PLATE
1
Cleared 510(K)
K
81
2818
TITERTEK AUTODROP
1
Cleared 510(K)
K
81
0719
REPLICA PLATER
1
Cleared 510(K)
K
81
0659
AUTODILUTER III
1
Cleared 510(K)
K
81
0229
SCEPTOR SYSTEM AUTOMATED MODEL 216
1
Cleared 510(K)
K
80
3244
ASSAY STRIPS
1
Cleared 510(K)
K
81
0039
MIC-2000 INOCULUM TRAY LID
1
Cleared 510(K)
K
80
3242
SEROCLUSTER EIA PLATES
1
Cleared 510(K)
K
80
3243
SEROCLUSTER FLEXIBLE VINYL U & V PL.
1
Cleared 510(K)
K
81
0022
SRD III
1
Cleared 510(K)
K
80
3252
MICROMEDIC REAGENT DISPENSER
1
Cleared 510(K)
K
80
2857
IMMULON REMOVAWELL STRIPS #011-010-6301
1
Cleared 510(K)
K
80
1305
HIPPURATE DISK
1
Cleared 510(K)
K
80
1437
DISPENSING SEROLOGICAL PIPET
1
Cleared 510(K)
K
80
0989
DYNAWASHER II
1
Cleared 510(K)
K
80
0240
SEROCLUSTER U AND V
1
Cleared 510(K)
K
79
0974
MIC-2000 INOCULATOR TEMPLATE
1
Cleared 510(K)
K
79
0971
MIC-2000 QUAD INOCULUM TRAY
1
Cleared 510(K)
K
79
0957
HISTO-DISPENSER
1
Cleared 510(K)
K
79
0956
HISTO-OILER
1
Cleared 510(K)
K
79
0076
INOCULATOR, MIC-2000 DISPOSABLE
1
Cleared 510(K)
K
78
1802
WASHER SYSTEM, MICROELISA
1
Cleared 510(K)
K
78
1942
MINIWASH
1
Cleared 510(K)
K
76
1149
MODEL 203 DISPENSER
1
Cleared 510(K)
JTL
Plasma, Coagulase, Human, Horse And Rabbit
1
Product Code
JTM
Anaerobic Box Glove
1
Product Code
JTO
Discs, Strips And Reagents, Microorganism Differentiation
1
Product Code
JTQ
Bath, Incubators/Water, All
1
Product Code
JTR
Kit, Quality Control For Culture Media
1
Product Code
JTW
System, Transport, Aerobic
1
Product Code
JTX
Transport Systems, Anaerobic
1
Product Code
JTY
Culture Media, For Isolation Of Pathogenic Neisseria
2
Product Code
JWX
Kit, Screening, Staphylococcus Aureus
1
Product Code
JWZ
Kit, Screening, Trichomonas
1
Product Code
JXA
Kit, Screening, Urine
1
Product Code
JXB
Kit, Identification, Yeast
1
Product Code
JXC
Kit, Screening, Yeast
1
Product Code
KZB
Automated Colony Counter
1
Product Code
KZC
Manual Colony Counter
1
Product Code
KZI
Culture Media, Enriched
1
Product Code
KZJ
Device, Gas Generating
1
Product Code
KZK
Reader, Zone, Automated
1
Product Code
LGA
Device, Oxidase Test For Gonorrhea
3
Product Code
LIB
Device, General Purpose, Microbiology, Diagnostic
1
Product Code
LIO
Device, Specimen Collection
1
Product Code
LJF
Device, Antimicrobial Drug Removal
1
Product Code
LJG
Quality Control Slides
1
Product Code
LKS
Device, Parasite Concentration
1
Product Code
LLH
Reagents, Clostridium Difficile Toxin
1
Product Code
LQL
Gram Positive Identification Panel
1
Product Code
LQM
Gram Negative Identification Panel
1
Product Code
LRH
Instrument For Auto Reader Of Overnight Microorganism Identification System
1
Product Code
LSC
Neisseria Controls
1
Product Code
LTS
Test Reagents, Neisseria Gonorrhoeae Biochemical
1
Product Code
MCB
Antigen, C. Difficile
1
Product Code
MDB
System, Blood Culturing
1
Product Code
MJK
Dna Probe, Trichomonas Vaginalis
1
Product Code
MJM
Dna Probe, Gardnerella Vaginalis
1
Product Code
MLA
Dna Probe, Yeast
1
Product Code
NZS
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
1
Product Code
OMN
C. Difficile Nucleic Acid Amplification Test Assay
1
Product Code
OUS
Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
1
Product Code
PGX
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
2
Product Code
PPU
Microbial Colony Image Assessment System
2
Product Code
PQZ
Gbs Culture Media, Selective And Differential
1
Product Code
QBD
Microbial Nucleic Acid Storage And Stabilization Device
2
Product Code
QBQ
System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
1
Product Code
QMC
Transport Medium, Notified Per The Vtm Guidance
1
Product Code
QQY
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
2
Product Code
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
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 20 June 2025 at 11:06 pm
MI
/
subpart-c—microbiology-devices
/
JTC
/
K761149
View Source
MODEL 203 DISPENSER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K761149
510(k) Type
Traditional
Applicant
BECKMAN INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/9/1976
Days to Decision
13 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
GMB
Light, Wood'S, Fluorescence
GTL
Phages, Staphylococcal Typing, All Types
JRZ
Media, Culture, Amino Acid Assay
JSA
Culture Media, Antibiotic Assay
JSB
Culture Media, Vitamin Assay
JSC
Culture Media, General Nutrient Broth
JSD
Culture Media, Selective Broth
JSE
Culture Media, Multiple Biochemical Test
JSF
Culture Media, Single Biochemical Test
JSG
Culture Media, Non-Selective And Non-Differential
JSH
Culture Media, Non-Selective And Differential
JSI
Culture Media, Selective And Differential
JSJ
Culture Media, Selective And Non-Differential
JSK
Supplement, Culture Media
JSL
Culture Media, Anaerobic Transport
JSM
Culture Media, Non-Propagating Transport
JSN
Culture Media, Propagating Transport
JSP
Kit, Anaerobic Identification
JSR
Kit, Identification, Dermatophyte
JSS
Kit, Identification, Enterobacteriaceae
JST
Kit, Fastidious Organisms
JSW
Kit, Identification, Glucose Nonfermenter
JSX
Kit, Identification, Neisseria Gonorrhoeae
JSY
Kit, Identification, Mycobacteria
JSZ
Kit, Identification, Pseudomonas
JTA
Monitor, Microbial Growth
JTB
Device, Media Dispensing/Stacking
JTC
Device, Microtiter Diluting/Dispensing
K
92
4907
FILTERMATE UNIVERSAL HARVESTER
K
90
1808
MICROMATE 196 MODEL A961960
K
89
4645
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
K
89
2369
MULTI-PROBE HEAD PLUS
K
89
1765
GENETIC SYSTEMS PIPETTOR/DILUTOR
K
89
1766
GENETIC SYSTEMS MICROPLATE STRIP WASHER
K
89
1768
GENETIC SYSTEMS MICROPLATE WASHER
K
88
4695
WASHER 500 MICROELISA SYSTEM
K
88
4125
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
K
87
4598
DYNATECH MR 250 MANUAL MICROELISA READER
K
87
3542
MICROPLATE AUTO-WASHER (MOTORIZED STAGE)
K
87
1945
MICROLAB AT
K
86
3423
CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
K
86
3374
CODE-A-WELL SERIES 1-600, 1-625
K
86
2802
MULTI-CHANNEL MICROPIPETTES
K
86
2066
TITERTEK MICROPLATE WASHER S-12
K
86
0617
POLYPET
K
85
3920
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER
K
85
3380
SPR 2 AUTODILUTER
K
85
1020
MIC-CONCEPT INOCULATOR
K
85
1019
MIC-CONCEPT INOCULUM SEED TRAY
K
85
0908
TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA
K
85
0249
BIO-TEK AUTOMATED MICROPLATE WASHER EL402
K
85
0371
INTIWASH MANUAL MICROPLATE WASHER
K
84
4893
SLT 223 DISPENSER FOR MICROTITERPLATES
K
84
4891
SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES
K
84
4568
TITERTEK DULUTER/DISPENSER 78-640-00
K
84
4552
BIO-STAT III PLATE WASHER
K
84
4500
TITERTEK MICROPLATE WASHER 120
K
84
3272
T.I.M.E. DISPENSER
K
84
2848
CODE-A-WELL 350 MICROTITRATION STRIPS
K
83
1462
API UNISCEPT PLUS 140 INOCULATOR
K
83
2203
MULTI-TITER DISPENSER
K
83
1640
WASHER 6000 MICRO-C LISA SYSTEM
K
83
1644
PIPETTE 12 CHANNEL
K
83
1341
API UNISCEPT PLUS AUTOINOCULATOR
K
83
0059
MUELLER HINTON W/50% SHEEP BLOOD
K
82
3137
OCTAPETTES
K
82
3218
DISPOSABLE DISPENSE MANIFOLD
K
82
1961
96 WELL DISPENSER
K
82
0992
MICROPLATE WASHING DEVICE
K
82
0821
MIC-2000 PLUS, 96 CHANNEL DISPENSER
K
81
2860
IMMUNOASSAY PLATE
K
81
2818
TITERTEK AUTODROP
K
81
0719
REPLICA PLATER
K
81
0659
AUTODILUTER III
K
81
0229
SCEPTOR SYSTEM AUTOMATED MODEL 216
K
80
3244
ASSAY STRIPS
K
81
0039
MIC-2000 INOCULUM TRAY LID
K
80
3242
SEROCLUSTER EIA PLATES
K
80
3243
SEROCLUSTER FLEXIBLE VINYL U & V PL.
K
81
0022
SRD III
K
80
3252
MICROMEDIC REAGENT DISPENSER
K
80
2857
IMMULON REMOVAWELL STRIPS #011-010-6301
K
80
1305
HIPPURATE DISK
K
80
1437
DISPENSING SEROLOGICAL PIPET
K
80
0989
DYNAWASHER II
K
80
0240
SEROCLUSTER U AND V
K
79
0974
MIC-2000 INOCULATOR TEMPLATE
K
79
0971
MIC-2000 QUAD INOCULUM TRAY
K
79
0957
HISTO-DISPENSER
K
79
0956
HISTO-OILER
K
79
0076
INOCULATOR, MIC-2000 DISPOSABLE
K
78
1802
WASHER SYSTEM, MICROELISA
K
78
1942
MINIWASH
K
76
1149
MODEL 203 DISPENSER
JTL
Plasma, Coagulase, Human, Horse And Rabbit
JTM
Anaerobic Box Glove
JTO
Discs, Strips And Reagents, Microorganism Differentiation
JTQ
Bath, Incubators/Water, All
JTR
Kit, Quality Control For Culture Media
JTW
System, Transport, Aerobic
JTX
Transport Systems, Anaerobic
JTY
Culture Media, For Isolation Of Pathogenic Neisseria
JWX
Kit, Screening, Staphylococcus Aureus
JWZ
Kit, Screening, Trichomonas
JXA
Kit, Screening, Urine
JXB
Kit, Identification, Yeast
JXC
Kit, Screening, Yeast
KZB
Automated Colony Counter
KZC
Manual Colony Counter
KZI
Culture Media, Enriched
KZJ
Device, Gas Generating
KZK
Reader, Zone, Automated
LGA
Device, Oxidase Test For Gonorrhea
LIB
Device, General Purpose, Microbiology, Diagnostic
LIO
Device, Specimen Collection
LJF
Device, Antimicrobial Drug Removal
LJG
Quality Control Slides
LKS
Device, Parasite Concentration
LLH
Reagents, Clostridium Difficile Toxin
LQL
Gram Positive Identification Panel
LQM
Gram Negative Identification Panel
LRH
Instrument For Auto Reader Of Overnight Microorganism Identification System
LSC
Neisseria Controls
LTS
Test Reagents, Neisseria Gonorrhoeae Biochemical
MCB
Antigen, C. Difficile
MDB
System, Blood Culturing
MJK
Dna Probe, Trichomonas Vaginalis
MJM
Dna Probe, Gardnerella Vaginalis
MLA
Dna Probe, Yeast
NZS
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
OMN
C. Difficile Nucleic Acid Amplification Test Assay
OUS
Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
PGX
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
PPU
Microbial Colony Image Assessment System
PQZ
Gbs Culture Media, Selective And Differential
QBD
Microbial Nucleic Acid Storage And Stabilization Device
QBQ
System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
QMC
Transport Medium, Notified Per The Vtm Guidance
QQY
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Subpart D—Serological Reagents
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
subpart-c—microbiology-devices
/
JTC
/
K761149
View Source
MODEL 203 DISPENSER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K761149
510(k) Type
Traditional
Applicant
BECKMAN INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/9/1976
Days to Decision
13 days