K023947 is an FDA 510(k) clearance for the GC OIA. This device is classified as a Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae (Class II - Special Controls, product code LIR).
Submitted by Thermo Biostar, Inc. (Louisville, US). The FDA issued a Cleared decision on April 17, 2003, 141 days after receiving the submission on November 27, 2002.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K023947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2002 |
| Decision Date | April 17, 2003 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LIR — Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |