K942753 is an FDA 510(k) clearance for the ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER. This device is classified as a System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (Class I - General Controls, product code EYZ).
Submitted by Researched, Novel Medical Devices (Rn/Md) (Sherman Oaks, US). The FDA issued a Cleared decision on November 2, 1994, 145 days after receiving the submission on June 10, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K942753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1994 |
| Decision Date | November 02, 1994 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EYZ — System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |