K862665 is an FDA 510(k) clearance for the NOVACYTE-U. This device is classified as a Container, Specimen Mailer And Storage, Sterile (Class I - General Controls, product code KDT).
Submitted by Xsirius Medical, Inc. (Rolling Hills Estates, US). The FDA issued a Cleared decision on September 4, 1986, 52 days after receiving the submission on July 14, 1986.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K862665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1986 |
| Decision Date | September 04, 1986 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KDT — Container, Specimen Mailer And Storage, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3250 |