K831343 is an FDA 510(k) clearance for the CMV RQ BIO-ENZABEAD KIT. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II - Special Controls, product code LFZ).
Submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983, 105 days after receiving the submission on April 25, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K831343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1983 |
| Decision Date | August 08, 1983 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |