| Device Type ID | 3990 |
| Device Name | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Regulation Description | Amniotic Fluid Sampler (amniocentesis Tray). |
| 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 | 884.1550 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HIO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3990 |
| Device | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Product Code | HIO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Amniotic Fluid Sampler (amniocentesis Tray). |
| CFR Regulation Number | 884.1550 [🔎] |
| Device Problems | |
|---|---|
Difficult To Position | 1 |
| Total Device Problems | 1 |