The following data is part of a premarket notification filed by Hygeia Sciences with the FDA for Hygeia Gc Test.
| Device ID | K881064 |
| 510k Number | K881064 |
| Device Name: | HYGEIA GC TEST |
| Classification | Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae |
| Applicant | HYGEIA SCIENCES 330 NEVADA ST. Newton, MA 02160 |
| Contact | Cannon, Phd |
| Correspondent | Cannon, Phd HYGEIA SCIENCES 330 NEVADA ST. Newton, MA 02160 |
| Product Code | LIR |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-14 |
| Decision Date | 1988-06-02 |