Innotron of Oregon, Inc.
Mchenry, IL, US
Innotron of Oregon, Inc. appears in FDA device records in Mchenry, IL. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Innotron of Oregon, Inc. between 1980 and 1990. The busiest year on record is 1987, with 9. The most recent is 1990, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1987 | 9 |
| 1989 | 7 |
| 1990 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K903101 | INNOFLUOR (TM) AMIKACIN CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | KLQ | Substantially Equivalent | |
| K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | LFW | Substantially Equivalent | |
| K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR | LEH | Substantially Equivalent | |
| K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | LGS | Substantially Equivalent | |
| K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR | LBZ | Substantially Equivalent | |
| K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | LGQ | Substantially Equivalent | |
| K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | LCD | Substantially Equivalent | |
| K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | LGI | Substantially Equivalent | |
| K895827 | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET | LGR | Substantially Equivalent | |
| K895828 | INNOFLUOR DIGOXIN REAGENT SET | LCS | Substantially Equivalent | |
| K895826 | INNOFLUOR DIGOXIN CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K893506 | INNOFLUOR CARBAMAZEPINE CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K893507 | INNOFLUOR CARBAMAZEPINE REAGENT SET | KLT | Substantially Equivalent | |
| K892212 | INNOFLUOR(TM) QUINDINE CALIBATOR SET | DLJ | Substantially Equivalent | |
| K892208 | INNOFLUOR(TM) QUINIDINE REAGENT SET | LBZ | Substantially Equivalent | |
| K872563 | INNOTRON INNOFLUOR PHEYTOIN REAGENT SET | LGR | Substantially Equivalent | |
| K872579 | INNOFLUOR VANCOMYCIN REAGENT SET | LEH | Substantially Equivalent | |
| K872562 | INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET | LFW | Substantially Equivalent | |
| K872644 | INNOFLUOR VANCOMYCIN CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K872463 | INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K872462 | INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K872461 | INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K872349 | INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K872142 | INNOFLUOR PHENYTOIN CALIBRATOR SET | DLJ | Substantially Equivalent | |
| K830101 | COLORIMETERS SERIES ONE 12 | JJQ | Substantially Equivalent | |
| K822942 | INNOTRON FLUORIMETER SERIES ONE-10 | KHO | Substantially Equivalent | |
| K800601 | HYDRAGAMMA 16 | JJJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DLJCalibrators, Drug Specific
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JJJCounter (Beta, Gamma) For Clinical Use
- KLTEnzyme Immunoassay, Carbamazepine
- LCDEnzyme Immunoassay, Gentamicin
- LBZEnzyme Immunoassay, Quinidine
- LGIFluorescence Polarization Immunoassay, Carbamazepine
- LGRFluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
- LGQFluorescence Polarization Immunoassay, Phenobarbital
- LGSFluorescence Polarization Immunoassay, Theophylline
- LFWFluorescence Polarization Immunoassay, Tobramycin
- KHOFluorometer, For Clinical Use
- KLQRadioimmunoassay, Amikacin
- LCSRadioimmunoassay, Digoxin (125-I)
- LEHRadioimmunoassay, Vancomycin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain