Definition: This Product Code Is The Class II Exempt Counterpart Of MQK, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k))
| Device Type ID | 4091 |
| Device Name | Labware, Assisted Reproduction, Exempt |
| Physical State | Exemption Is Limited To Dishes And Plates That Are Intended For General Assisted Reproduction Technology Procedures. |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of MQK, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Target Area | This Product Code Is The Class II Exempt Counterpart Of MQK, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Regulation Description | Assisted Reproduction Labware. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 884.6160 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PUD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4091 |
| Device | Labware, Assisted Reproduction, Exempt |
| Product Code | PUD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assisted Reproduction Labware. |
| CFR Regulation Number | 884.6160 [🔎] |