Company ยท US
Innotron Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1985. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCQ | Fluorescent Immunoassay Gentamicin | 1 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 1 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 1 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | 1 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 1985 | K850629 | INNOFLUOR THEOPHYLLINE Innotron Diagnostics | LGS |
| Jan 8, 1985 | K844721 | INNOFLUOR PRIMIDONE Innotron Diagnostics | LKT |
| May 31, 1984 | K841866 | INNOFLOUR TOBRAMYCIN Innotron Diagnostics | LFW |
| May 31, 1984 | K841865 | INNOFLOUR GENTAMICIN Innotron Diagnostics | LCQ |
| May 23, 1984 | K841707 | INNOFLUOR PHENOBARBITAL Innotron Diagnostics | LGQ |
| May 22, 1984 | K841706 | INNOFLUOR PHENYTOIN Innotron Diagnostics | LGR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||