The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Premier Hsv Plus.
| Device ID | K953839 |
| 510k Number | K953839 |
| Device Name: | PREMIER HSV PLUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allen D Nickol |
| Correspondent | Allen D Nickol 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 | 1995-08-16 |
| Decision Date | 1996-05-23 |
| Summary: | summary |