The following data is part of a premarket notification filed by Hygeia Sciences with the FDA for Hygeia Rapid Strep A Test.
| Device ID | K862133 |
| 510k Number | K862133 |
| Device Name: | HYGEIA RAPID STREP A TEST |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | HYGEIA SCIENCES 330 NEVADA ST. Newton, MA 02160 |
| Contact | Berke, Ph.d. |
| Correspondent | Berke, Ph.d. HYGEIA SCIENCES 330 NEVADA ST. Newton, MA 02160 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-06-25 |