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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
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
K
21
3869
EmbryoSlide+ ic8 dish
2
Cleared 510(K)
K
20
3626
SureStrip Vitrification Straw, SureLock Vitrification Straw
2
Cleared 510(K)
K
20
1213
Pasteur Pipette 3mL, Pasteur Pipette 1mL
2
Cleared 510(K)
K
20
0815
VitriGuard
2
Cleared 510(K)
K
18
1461
Rapid-i™ Kit
2
Cleared 510(K)
K
18
1469
Cryotop®US-flash and Cryotop®US-scoop
2
Cleared 510(K)
K
18
0740
VitriGuard
2
Cleared 510(K)
K
17
3075
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
2
Cleared 510(K)
K
17
2751
iVitri Straw
2
Cleared 510(K)
K
16
2640
iVitri EZ
2
Cleared 510(K)
K
16
2833
VitriGuard
2
Cleared 510(K)
K
16
2051
Cryotec
2
Cleared 510(K)
K
15
3027
Cryotop US
2
Cleared 510(K)
K
15
0961
EmbryoSlide Culture Dish
2
Cleared 510(K)
K
15
0756
Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
2
Cleared 510(K)
K
14
0207
RAPID-I KIT
2
Cleared 510(K)
K
14
1663
EEVA DISH (WITH 12 MICROWELLS)
2
Cleared 510(K)
K
13
3295
QUALIS
2
Cleared 510(K)
K
14
0072
CRYOTOP(R) SC
2
Cleared 510(K)
K
13
1145
PROINSERT
2
Cleared 510(K)
K
12
2982
CRYOLOCK
2
Cleared 510(K)
K
12
3641
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
2
Cleared 510(K)
K
11
2644
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
2
Cleared 510(K)
K
11
2695
CRYOTOP
2
Cleared 510(K)
K
11
2413
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
2
Cleared 510(K)
K
10
3028
EEVATM PETRI DISH
2
Cleared 510(K)
K
10
0596
CRYOPETTE
2
Cleared 510(K)
K
09
2398
HSV STRAW
2
Cleared 510(K)
K
09
0832
RAPID-I
2
Cleared 510(K)
K
09
0429
NUNC IVF CENTERWELL AND ICSI DISHES
2
Cleared 510(K)
K
08
1896
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
2
Cleared 510(K)
K
08
0395
SUNIVF DISHES
2
Cleared 510(K)
K
07
0047
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
2
Cleared 510(K)
K
05
2457
PICSI SPERM SELECTION DEVICE
2
Cleared 510(K)
K
04
0717
NUNC IVF MULTIDISH 4 WELLS NUNCLON
2
Cleared 510(K)
K
00
0915
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
2
Cleared 510(K)
K
99
4361
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
2
Cleared 510(K)
K
99
3881
GENX CULTURE DISH
2
Cleared 510(K)
K
99
0941
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
2
Cleared 510(K)
K
99
1251
FALCON IVF ONE WELL DISH
2
Cleared 510(K)
K
99
1253
FALCON IVF ROUND DISH
2
Cleared 510(K)
K
99
1249
FALCON IVF FOUR WELL PLATE
2
Cleared 510(K)
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 26 May 2023 at 11:04 pm
OB
/
assisted-reproduction-devices
/
MQK
/
K123641
View Source
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123641
510(k) Type
Traditional
Applicant
HERTART
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
7/3/2013
Days to Decision
219 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
MQH
Microtools, Assisted Reproduction (Pipettes)
MQI
Microtool Fabrication, Assisted Reproduction
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
MQK
Labware, Assisted Reproduction
K
21
3869
EmbryoSlide+ ic8 dish
K
20
3626
SureStrip Vitrification Straw, SureLock Vitrification Straw
K
20
1213
Pasteur Pipette 3mL, Pasteur Pipette 1mL
K
20
0815
VitriGuard
K
18
1461
Rapid-i™ Kit
K
18
1469
Cryotop®US-flash and Cryotop®US-scoop
K
18
0740
VitriGuard
K
17
3075
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
K
17
2751
iVitri Straw
K
16
2640
iVitri EZ
K
16
2833
VitriGuard
K
16
2051
Cryotec
K
15
3027
Cryotop US
K
15
0961
EmbryoSlide Culture Dish
K
15
0756
Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
K
14
0207
RAPID-I KIT
K
14
1663
EEVA DISH (WITH 12 MICROWELLS)
K
13
3295
QUALIS
K
14
0072
CRYOTOP(R) SC
K
13
1145
PROINSERT
K
12
2982
CRYOLOCK
K
12
3641
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
K
11
2644
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
K
11
2695
CRYOTOP
K
11
2413
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
K
10
3028
EEVATM PETRI DISH
K
10
0596
CRYOPETTE
K
09
2398
HSV STRAW
K
09
0832
RAPID-I
K
09
0429
NUNC IVF CENTERWELL AND ICSI DISHES
K
08
1896
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
K
08
0395
SUNIVF DISHES
K
07
0047
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
K
05
2457
PICSI SPERM SELECTION DEVICE
K
04
0717
NUNC IVF MULTIDISH 4 WELLS NUNCLON
K
00
0915
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
K
99
4361
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
K
99
3881
GENX CULTURE DISH
K
99
0941
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
K
99
1251
FALCON IVF ONE WELL DISH
K
99
1253
FALCON IVF ROUND DISH
K
99
1249
FALCON IVF FOUR WELL PLATE
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
/
MQK
/
K123641
View Source
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123641
510(k) Type
Traditional
Applicant
HERTART
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
7/3/2013
Days to Decision
219 days
Submission Type
Summary