K780167 is an FDA 510(k) clearance for the CATH KIT, URINE SPECIMEN. This device is classified as a Container, Specimen, Sterile (Class I - General Controls, product code FMH).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1978, 19 days after receiving the submission on February 2, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K780167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1978 |
| Decision Date | February 21, 1978 |
| Days to Decision | 19 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 |