The following data is part of a premarket notification filed by Concord/portex with the FDA for Amniotic Fluid Sampler (amniocentesis Tray).
| Device ID | K896031 |
| 510k Number | K896031 |
| Device Name: | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-16 |
| Decision Date | 1990-01-12 |