The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Meritecastrep (tm).
| Device ID | K821100 |
| 510k Number | K821100 |
| Device Name: | MERITECASTREP (TM) |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-20 |
| Decision Date | 1982-05-13 |