The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Meritec-strep Group A Beta-hemolytic.
| Device ID | K831599 |
| 510k Number | K831599 |
| Device Name: | MERITEC-STREP GROUP A BETA-HEMOLYTIC |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-17 |
| Decision Date | 1983-08-11 |