K031606 is an FDA 510(k) clearance for the ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II - Special Controls, product code LFX).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 20, 2003, 29 days after receiving the submission on May 22, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K031606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2003 |
| Decision Date | June 20, 2003 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LFX — Enzyme Linked Immunoabsorbent Assay, Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |