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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
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Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
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General Hospital
Review Panel
Hematology
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Microbiology
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Neurology
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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
MQL
Media, Reproductive
2
Product Code
K
21
2410
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
2
Cleared 510(K)
K
20
2862
Gx-IVF, Gx-TL, Gx-MOPS PLUS
2
Cleared 510(K)
K
19
3285
V-ONESTEP
2
Cleared 510(K)
K
19
2503
GM501 Wash with Phenol Red and Gentamicin
2
Cleared 510(K)
K
20
0249
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
2
Cleared 510(K)
K
20
0408
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
2
Cleared 510(K)
K
19
3522
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
2
Cleared 510(K)
K
19
2845
Sperm Freeze, Sperm Fridge
2
Cleared 510(K)
K
20
0680
Synvitro Hyadase
2
Cleared 510(K)
K
19
2644
GM501 SpermAir and GM501 SpermActive
2
Cleared 510(K)
Show All 229 Submissions
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
/
MQL
/
K200408
View Source
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200408
510(k) Type
Traditional
Applicant
Shenzhen VitaVitro Biotech Co.,Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/16/2020
Days to Decision
240 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
MQL
Media, Reproductive
K
21
2410
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
K
20
2862
Gx-IVF, Gx-TL, Gx-MOPS PLUS
K
19
3285
V-ONESTEP
K
19
2503
GM501 Wash with Phenol Red and Gentamicin
K
20
0249
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
K
20
0408
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
K
19
3522
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
K
19
2845
Sperm Freeze, Sperm Fridge
K
20
0680
Synvitro Hyadase
K
19
2644
GM501 SpermAir and GM501 SpermActive
Show All 229 Submissions
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
/
MQL
/
K200408
View Source
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200408
510(k) Type
Traditional
Applicant
Shenzhen VitaVitro Biotech Co.,Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/16/2020
Days to Decision
240 days
Submission Type
Summary