Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- Assisted Reproduction DevicesCFR Sub-Part
- MQENeedle, Assisted Reproduction2Product Code
- MQFCatheter, Assisted Reproduction2Product Code
- MQGAccessory, Assisted Reproduction2Product Code
- MQHMicrotools, Assisted Reproduction (Pipettes)2Product Code
- MQIMicrotool Fabrication, Assisted Reproduction2Product Code
- MQJMicromanipulators And Microinjectors, Assisted Reproduction2Product Code
- MQKLabware, Assisted Reproduction2Product Code
- K213869EmbryoSlide+ ic8 dish2Cleared 510(K)
- K203626SureStrip Vitrification Straw, SureLock Vitrification Straw2Cleared 510(K)
- K201213Pasteur Pipette 3mL, Pasteur Pipette 1mL2Cleared 510(K)
- K200815VitriGuard2Cleared 510(K)
- K181461Rapid-i™ Kit2Cleared 510(K)
- K181469Cryotop®US-flash and Cryotop®US-scoop2Cleared 510(K)
- K180740VitriGuard2Cleared 510(K)
- K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)2Cleared 510(K)
- K172751iVitri Straw2Cleared 510(K)
- K162640iVitri EZ2Cleared 510(K)
- Show All 42 Submissions
- 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
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Prosthetic DevicesCFR Sub-Part
- Clinical Chemistry Test SystemsCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Rapid-i™ Kit
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K181461
- 510(k) Type
- Traditional
- Applicant
- Vitrolife Sweden AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/4/2019
- Days to Decision
- 214 days
- Submission Type
- Summary