The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Immunocard Rotavirus.
| Device ID | K933587 |
| 510k Number | K933587 |
| Device Name: | IMMUNOCARD ROTAVIRUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allan D Nickol |
| Correspondent | Allan D Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-26 |
| Decision Date | 1994-02-03 |