K860529 is an FDA 510(k) clearance for the ROTALEX. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I - General Controls, product code LIQ).
Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on March 4, 1986, 21 days after receiving the submission on February 11, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3405.
| 510(k) Number | K860529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1986 |
| Decision Date | March 04, 1986 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3405 |