Company ยท US
Innotron of Oregon, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1990. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DLJ | Calibrators, Drug Specific | 10 |
| LBZ | Enzyme Immunoassay, Quinidine | 2 |
| LEH | Radioimmunoassay, Vancomycin | 2 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 2 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | 2 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| KHO | Fluorometer, For Clinical Use | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| LCD | Enzyme Immunoassay, Gentamicin | 1 |
| LCS | Radioimmunoassay, Digoxin (125-I) | 1 |
| LGI | Fluorescence Polarization Immunoassay, Carbamazepine | 1 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 1 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 22, 1990 | K903101 | INNOFLUOR (TM) AMIKACIN CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Aug 9, 1990 | K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET Innotron of Oregon, Inc. | KLQ |
| Apr 20, 1990 | K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR Innotron of Oregon, Inc. | LFW |
| Apr 19, 1990 | K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR Innotron of Oregon, Inc. | LEH |
| Apr 12, 1990 | K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA Innotron of Oregon, Inc. | LGS |
| Apr 12, 1990 | K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR Innotron of Oregon, Inc. | LBZ |
| Apr 12, 1990 | K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA Innotron of Oregon, Inc. | LGQ |
| Apr 12, 1990 | K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR Innotron of Oregon, Inc. | LCD |
| Apr 12, 1990 | K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA Innotron of Oregon, Inc. | LGI |
| Oct 31, 1989 | K895827 | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET Innotron of Oregon, Inc. | LGR |
| Oct 30, 1989 | K895828 | INNOFLUOR DIGOXIN REAGENT SET Innotron of Oregon, Inc. | LCS |
| Oct 30, 1989 | K895826 | INNOFLUOR DIGOXIN CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Aug 15, 1989 | K893506 | INNOFLUOR CARBAMAZEPINE CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Aug 11, 1989 | K893507 | INNOFLUOR CARBAMAZEPINE REAGENT SET Innotron of Oregon, Inc. | KLT |
| Jun 9, 1989 | K892212 | INNOFLUOR(TM) QUINDINE CALIBATOR SET Innotron of Oregon, Inc. | DLJ |
| Jun 9, 1989 | K892208 | INNOFLUOR(TM) QUINIDINE REAGENT SET Innotron of Oregon, Inc. | LBZ |
| Aug 21, 1987 | K872563 | INNOTRON INNOFLUOR PHEYTOIN REAGENT SET Innotron of Oregon, Inc. | LGR |
| Aug 17, 1987 | K872579 | INNOFLUOR VANCOMYCIN REAGENT SET Innotron of Oregon, Inc. | LEH |
| Aug 17, 1987 | K872562 | INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET Innotron of Oregon, Inc. | LFW |
| Jul 21, 1987 | K872644 | INNOFLUOR VANCOMYCIN CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Jul 21, 1987 | K872463 | INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Jul 21, 1987 | K872462 | INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Jul 21, 1987 | K872461 | INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Jul 21, 1987 | K872349 | INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Jul 21, 1987 | K872142 | INNOFLUOR PHENYTOIN CALIBRATOR SET Innotron of Oregon, Inc. | DLJ |
| Jan 28, 1983 | K830101 | COLORIMETERS SERIES ONE 12 Innotron of Oregon, Inc. | JJQ |
| Dec 9, 1982 | K822942 | INNOTRON FLUORIMETER SERIES ONE-10 Innotron of Oregon, Inc. | KHO |
| Apr 10, 1980 | K800601 | HYDRAGAMMA 16 Innotron of Oregon, Inc. | JJJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||