K844255 is an FDA 510(k) clearance for the GENT-L-KARE STERILE I.V. START KIT. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on December 19, 1984, 47 days after receiving the submission on November 2, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K844255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1984 |
| Decision Date | December 19, 1984 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |