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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
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Assisted Reproduction Devices
CFR Sub-Part
MQE
Needle, Assisted Reproduction
2
Product Code
MQF
Catheter, Assisted Reproduction
2
Product Code
MQG
Accessory, Assisted Reproduction
2
Product Code
K
18
0188
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
2
Cleared 510(K)
K
17
3264
EmbryoScope+
2
Cleared 510(K)
K
18
0304
Geri Embryo Incubator and Geri Dish
2
Cleared 510(K)
K
17
1736
Geri Embryo Incubator and Geri Dish
2
Cleared 510(K)
K
16
0753
COOK Vacuum Pump
2
Cleared 510(K)
K
16
0504
RI Witness Embryology Heated Plate
2
Cleared 510(K)
K
15
1357
MIRI TL
2
Cleared 510(K)
K
13
3712
EMBRYOVIEWER SOFTWARE
2
Cleared 510(K)
K
13
2870
Origio Gas Line Filter
2
Cleared 510(K)
K
13
3742
XQ-1 INCUBATOR
2
Cleared 510(K)
K
12
1566
PLANER BT37 INCUBATOR
2
Cleared 510(K)
K
11
3075
EMBRYO VIEWER SOFTWARE
2
Cleared 510(K)
K
11
1715
EMBRYOSCOPE
2
Cleared 510(K)
K
10
1988
HEAL FORCE CO2 INCUBATOR
2
Cleared 510(K)
K
09
2183
EMBRYOSCOPE AND EMBRYOSLIDE
2
Cleared 510(K)
K
05
0197
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
2
Cleared 510(K)
K
04
1952
ZIVF-AIRE
2
Cleared 510(K)
K
03
2086
KRYO ART CONTROLLED RATE FREEZER
2
Cleared 510(K)
K
03
2526
BINDER CO2 INCUBATOR SERIE CB
2
Cleared 510(K)
K
03
0525
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
2
Cleared 510(K)
K
02
3465
KENDRO HERACELL 240 INCUBATOR
2
Cleared 510(K)
K
01
1327
DB1 EMBRYO FREEZE
2
Cleared 510(K)
K
02
0560
WORKBENCH BY <GENX>
2
Cleared 510(K)
K
02
1042
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476
2
Cleared 510(K)
K
01
4160
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
2
Cleared 510(K)
K
01
3703
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
2
Cleared 510(K)
K
01
3401
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
2
Cleared 510(K)
K
00
2971
MTG - MINITUB HEATED STAGE SYSTEMS
2
Cleared 510(K)
K
00
1600
<GENX> CODA INCUBATOR CELLMATE
2
Cleared 510(K)
K
00
2961
MINITUB MULTI-PURPOSE CASSETTES
2
Cleared 510(K)
K
00
3184
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
2
Cleared 510(K)
K
00
2595
CBS STRAW
2
Cleared 510(K)
K
00
2805
KENDRO HERACELL CO2 INCUBATOR
2
Cleared 510(K)
K
00
1486
GENX CODA AIR PURIFICATION SYSTEM
2
Cleared 510(K)
K
00
1524
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
2
Cleared 510(K)
K
00
0394
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
2
Cleared 510(K)
K
99
2070
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
2
Cleared 510(K)
K
99
1216
HOFFMAN IVF-1
2
Cleared 510(K)
K
99
1408
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
2
Cleared 510(K)
K
99
1263
THERMOPLATE
2
Cleared 510(K)
K
99
1229
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
2
Cleared 510(K)
K
98
3642
COOK MINI-INCUBATOR
2
Cleared 510(K)
K
98
3609
COOK TEST TUBE HEATER
2
Cleared 510(K)
MQH
Microtools, Assisted Reproduction (Pipettes)
2
Product Code
MQI
Microtool Fabrication, Assisted Reproduction
2
Product Code
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
2
Product Code
MQK
Labware, Assisted Reproduction
2
Product Code
MQL
Media, Reproductive
2
Product Code
MRX
System, Assisted Reproduction Laser
2
Product Code
MTW
System, Water, Reproduction, Assisted, And Purification
2
Product Code
MTX
Microscope And Microscope Accessories, Reproduction, Assisted
1
Product Code
NNB
Needle, Reproduction, Assisted, Reprocessed
2
Product Code
PBH
Embryo Image Assessment System, Assisted Reproduction
2
Product Code
OYO
Culture, Intravaginal, Assisted Reproduction
2
Product Code
PUB
Accessory, Assisted Reproduction, Exempt
2
Product Code
PUC
Microtools, Assisted Reproduction (Pipettes), Exempt
2
Product Code
PUD
Labware, Assisted Reproduction, Exempt
2
Product Code
QKH
Assisted Reproduction Laminar Flow Workstation
2
Product Code
QKI
Media, Reproductive, Exempt
2
Product Code
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Prosthetic Devices
CFR Sub-Part
Clinical Chemistry Test Systems
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Physical Medicine Prosthetic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
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 2 June 2023 at 11:04 pm
OB
/
assisted-reproduction-devices
/
MQG
/
K002961
View Source
MINITUB MULTI-PURPOSE CASSETTES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002961
510(k) Type
Traditional
Applicant
ZANDER MEDICAL SUPPLIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/21/2000
Days to Decision
60 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Assisted Reproduction Devices
MQE
Needle, Assisted Reproduction
MQF
Catheter, Assisted Reproduction
MQG
Accessory, Assisted Reproduction
K
18
0188
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
K
17
3264
EmbryoScope+
K
18
0304
Geri Embryo Incubator and Geri Dish
K
17
1736
Geri Embryo Incubator and Geri Dish
K
16
0753
COOK Vacuum Pump
K
16
0504
RI Witness Embryology Heated Plate
K
15
1357
MIRI TL
K
13
3712
EMBRYOVIEWER SOFTWARE
K
13
2870
Origio Gas Line Filter
K
13
3742
XQ-1 INCUBATOR
K
12
1566
PLANER BT37 INCUBATOR
K
11
3075
EMBRYO VIEWER SOFTWARE
K
11
1715
EMBRYOSCOPE
K
10
1988
HEAL FORCE CO2 INCUBATOR
K
09
2183
EMBRYOSCOPE AND EMBRYOSLIDE
K
05
0197
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
K
04
1952
ZIVF-AIRE
K
03
2086
KRYO ART CONTROLLED RATE FREEZER
K
03
2526
BINDER CO2 INCUBATOR SERIE CB
K
03
0525
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
K
02
3465
KENDRO HERACELL 240 INCUBATOR
K
01
1327
DB1 EMBRYO FREEZE
K
02
0560
WORKBENCH BY <GENX>
K
02
1042
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476
K
01
4160
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K
01
3703
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
K
01
3401
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
K
00
2971
MTG - MINITUB HEATED STAGE SYSTEMS
K
00
1600
<GENX> CODA INCUBATOR CELLMATE
K
00
2961
MINITUB MULTI-PURPOSE CASSETTES
K
00
3184
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
K
00
2595
CBS STRAW
K
00
2805
KENDRO HERACELL CO2 INCUBATOR
K
00
1486
GENX CODA AIR PURIFICATION SYSTEM
K
00
1524
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
K
00
0394
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
K
99
2070
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K
99
1216
HOFFMAN IVF-1
K
99
1408
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
K
99
1263
THERMOPLATE
K
99
1229
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
K
98
3642
COOK MINI-INCUBATOR
K
98
3609
COOK TEST TUBE HEATER
MQH
Microtools, Assisted Reproduction (Pipettes)
MQI
Microtool Fabrication, Assisted Reproduction
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
MQK
Labware, Assisted Reproduction
MQL
Media, Reproductive
MRX
System, Assisted Reproduction Laser
MTW
System, Water, Reproduction, Assisted, And Purification
MTX
Microscope And Microscope Accessories, Reproduction, Assisted
NNB
Needle, Reproduction, Assisted, Reprocessed
PBH
Embryo Image Assessment System, Assisted Reproduction
OYO
Culture, Intravaginal, Assisted Reproduction
PUB
Accessory, Assisted Reproduction, Exempt
PUC
Microtools, Assisted Reproduction (Pipettes), Exempt
PUD
Labware, Assisted Reproduction, Exempt
QKH
Assisted Reproduction Laminar Flow Workstation
QKI
Media, Reproductive, Exempt
Cardiovascular Monitoring Devices
Cardiovascular Prosthetic Devices
Clinical Chemistry Test Systems
Diagnostic Devices
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
Obstetrical and Gynecological Monitoring Devices
Obstetrical and Gynecological Prosthetic Devices
Obstetrical and Gynecological Surgical Devices
Obstetrical and Gynecological Therapeutic Devices
Physical Medicine Prosthetic Devices
Prosthetic Devices
Therapeutic Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
assisted-reproduction-devices
/
MQG
/
K002961
View Source
MINITUB MULTI-PURPOSE CASSETTES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002961
510(k) Type
Traditional
Applicant
ZANDER MEDICAL SUPPLIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/21/2000
Days to Decision
60 days
Submission Type
Summary