The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Rapid Colorimetric Direct Strep A Test.
| Device ID | K874761 |
| 510k Number | K874761 |
| Device Name: | RAPID COLORIMETRIC DIRECT STREP A TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Contact | Ann Carter |
| Correspondent | Ann Carter NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-19 |
| Decision Date | 1988-02-19 |