K861172 is an FDA 510(k) clearance for the ROTAVIRUS LATEX AGGLUTINATION ASSAY. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I - General Controls, product code LIQ).
Submitted by Bartels Immunodiagnostic Supplies, Inc. (Bellevue, US). The FDA issued a Cleared decision on July 1, 1986, 95 days after receiving the submission on March 28, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3405.
| 510(k) Number | K861172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1986 |
| Decision Date | July 01, 1986 |
| Days to Decision | 95 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 |