The following data is part of a premarket notification filed by Innotron Diagnostics with the FDA for Innofluor Primidone.
| Device ID | K844721 |
| 510k Number | K844721 |
| Device Name: | INNOFLUOR PRIMIDONE |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | INNOTRON DIAGNOSTICS 6-A FARADAY Irvine, CA 92718 |
| Contact | Marija N Valentekov |
| Correspondent | Marija N Valentekov INNOTRON DIAGNOSTICS 6-A FARADAY Irvine, CA 92718 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-04 |
| Decision Date | 1985-01-08 |