K761230 is an FDA 510(k) clearance for the AMMOCENTESIS TRAY (KIT). This device is classified as a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I - General Controls, product code HIO).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1976, 7 days after receiving the submission on December 10, 1976.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1550.
| 510(k) Number | K761230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1976 |
| Decision Date | December 17, 1976 |
| Days to Decision | 7 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 |