K881064 is an FDA 510(k) clearance for the HYGEIA GC TEST. This device is classified as a Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae (Class II - Special Controls, product code LIR).
Submitted by Hygeia Sciences (Newton, US). The FDA issued a Cleared decision on June 2, 1988, 80 days after receiving the submission on March 14, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K881064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1988 |
| Decision Date | June 02, 1988 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIR — Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |