K780057 is an FDA 510(k) clearance for the URINE SAMPLE COLLECTION KIT. This device is classified as a Container, Specimen, Sterile (Class I - General Controls, product code FMH).
Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on February 21, 1978, 42 days after receiving the submission on January 10, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K780057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1978 |
| Decision Date | February 21, 1978 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMH — Container, Specimen, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3250 |