K960203 is an FDA 510(k) clearance for the G.E. STERILE AMNIOCENTESIS TRAY. This device is classified as a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I - General Controls, product code HIO).
Submitted by GE Medical Systems (Palm Harbor, US). The FDA issued a Cleared decision on March 14, 1996, 58 days after receiving the submission on January 16, 1996.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1550.
| 510(k) Number | K960203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1996 |
| Decision Date | March 14, 1996 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIO - Sampler, Amniotic Fluid (amniocentesis Tray) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.1550 |