The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Meritec(tm)-gc.
| Device ID | K874078 |
| 510k Number | K874078 |
| Device Name: | MERITEC(TM)-GC |
| Classification | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Clinton, Phd |
| Correspondent | Clinton, Phd MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | LIC |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-06 |
| Decision Date | 1987-12-09 |