The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Immunocard Stat! Rsv Model #750630.
| Device ID | K041445 |
| 510k Number | K041445 |
| Device Name: | IMMUNOCARD STAT! RSV MODEL #750630 |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Susan Rolih |
| Correspondent | Susan Rolih MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-01 |
| Decision Date | 2004-08-13 |
| Summary: | summary |