The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Immunocard Stat! Rotavirus.
| Device ID | K971585 |
| 510k Number | K971585 |
| Device Name: | IMMUNOCARD STAT! ROTAVIRUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| 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 | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101809 | K971585 | 000 |