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- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- MQENeedle, Assisted Reproduction2Product Code
- MQFCatheter, Assisted Reproduction2Product Code
- MQGAccessory, Assisted Reproduction2Product Code
- K242684Harioculture TL-16 Time-lapse Incubator2Cleared 510(K)
- K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)2Cleared 510(K)
- K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish2Cleared 510(K)
- K173264EmbryoScope+2Cleared 510(K)
- K180304Geri Embryo Incubator and Geri Dish2Cleared 510(K)
- K171736Geri Embryo Incubator and Geri Dish2Cleared 510(K)
- K160753COOK Vacuum Pump2Cleared 510(K)
- K160504RI Witness Embryology Heated Plate2Cleared 510(K)
- K151357MIRI TL2Cleared 510(K)
- K133712EMBRYOVIEWER SOFTWARE2Cleared 510(K)
Show All 45 Submissions
- MQHMicrotools, Assisted Reproduction (Pipettes)2Product Code
- MQIMicrotool Fabrication, Assisted Reproduction2Product Code
- MQJMicromanipulators And Microinjectors, Assisted Reproduction2Product Code
- MQKLabware, Assisted Reproduction2Product Code
- MQLMedia, Reproductive2Product Code
- MRXSystem, Assisted Reproduction Laser2Product Code
- MTWSystem, Water, Reproduction, Assisted, And Purification2Product Code
- MTXMicroscope And Microscope Accessories, Reproduction, Assisted1Product Code
- NNBNeedle, Reproduction, Assisted, Reprocessed2Product Code
- PBHEmbryo Image Assessment System, Assisted Reproduction2Product Code
- OYOCulture, Intravaginal, Assisted Reproduction2Product Code
- PUBAccessory, Assisted Reproduction, Exempt2Product Code
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt2Product Code
- PUDLabware, Assisted Reproduction, Exempt2Product Code
- QKHAssisted Reproduction Laminar Flow Workstation2Product Code
- QKIMedia, Reproductive, Exempt2Product Code
- QUJAutomated Cryopreservation Storage System2Product Code
- QYZAt Home Intravaginal Insemination System2Product Code
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K180188
- 510(k) Type
- Traditional
- Applicant
- Genea Biomedx Pty, Ltd.
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/7/2018
- Days to Decision
- 135 days
- Submission Type
- Summary