| Device Type ID | 4030 |
| Device Name | Labware, Assisted Reproduction |
| 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) |
| CFR Regulation Number | 884.6160 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4030 |
| Device | Labware, Assisted Reproduction |
| Product Code | MQK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assisted Reproduction Labware. |
| CFR Regulation Number | 884.6160 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AUXOGYN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HERTART | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KITAZATO BIOPHARMA CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KITAZATO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MENICON CO., LTD. NEW BUSINESS DIVISION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIDACON INTERNATIONAL AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORIGIO A/S | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
REPROLIFE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITROLIFE A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITROLIFE AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VITROLIFE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ORIGIO, Inc | II | Jun-30-2014 |