K894031 is an FDA 510(k) clearance for the PHARMASEAL GENETIC AMNIOCENTESIS TRAY. This device is classified as a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I - General Controls, product code HIO).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on August 4, 1989, 59 days after receiving the submission on June 6, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1550.
| 510(k) Number | K894031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | June 06, 1989 |
| Decision Date | August 04, 1989 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIO — Sampler, Amniotic Fluid (amniocentesis Tray) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.1550 |