The following data is part of a premarket notification filed by Hygeia Sciences with the FDA for Hygeia Sciences Urine Hcg Flow Thorugh Assay.
| Device ID | K862083 |
| 510k Number | K862083 |
| Device Name: | HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | HYGEIA SCIENCES 330 NEVADA ST. Newton, MA 02160 |
| Contact | Izak Bahar |
| Correspondent | Izak Bahar HYGEIA SCIENCES 330 NEVADA ST. Newton, MA 02160 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-02 |
| Decision Date | 1986-07-02 |