The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Premier Type Specific Hsv-2 Igg Elisa Test.
| Device ID | K984346 |
| 510k Number | K984346 |
| Device Name: | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Alan Nichol |
| Correspondent | Alan Nichol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-04 |
| Decision Date | 1999-06-25 |
| Summary: | summary |