Windsor Laboratories, Inc.
Mchenry, IL, US
Windsor Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(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
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Windsor Laboratories, Inc. between 1981 and 1987. The busiest year on record is 1986, with 7. The most recent is 1987, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1984 | 2 |
| 1985 | 2 |
| 1986 | 7 |
| 1987 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K873281 | CARBAMAZEPINE (FPIA) CALIBRATOR KIT | DLJ | Substantially Equivalent | |
| K873282 | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY | KLT | Substantially Equivalent | |
| K871486 | (FPIA) ASSAY BUFFER | JJF | Substantially Equivalent | |
| K870390 | PHENOBARBITAL (FPIA) CALIBRATOR KIT | DLJ | Substantially Equivalent | |
| K870389 | DIGOXIN (FPIA) CALIBRATOR KIT | DLJ | Substantially Equivalent | |
| K864333 | DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY | KXT | Substantially Equivalent | |
| K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | LGQ | Substantially Equivalent | |
| K863244 | AMIKACIN (FPIA) CALIBRATOR KIT | DLJ | Substantially Equivalent | |
| K862248 | AMIKACIN KIT (FPIA) | LGJ | Substantially Equivalent | |
| K861891 | TOBRAMYCIN (FPIA) CALIBRATOR KIT | JIS | Substantially Equivalent | |
| K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT | JIS | Substantially Equivalent | |
| K861769 | GENTAMICIN (FPIA) CALIBRATOR KIT | JIS | Substantially Equivalent | |
| K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT | JIS | Substantially Equivalent | |
| K854392 | TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU | LFW | Substantially Equivalent | |
| K852013 | GENTAMICIN KIT(FPIA) | LCQ | Substantially Equivalent | |
| K842586 | PHENYTOIN KIT FLUORESCENCE POLARIZATION | LGR | Substantially Equivalent | |
| K842585 | THEOPHYLLINE KIT FLUORESCENCE POLARIZA- | LER | Substantially Equivalent | |
| K811442 | KWIK-LAC BETA-LACTAMASE KITS | Substantially Equivalent | ||
| K811412 | NEISSERIA-KWIK | JSX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- JISCalibrator, Primary
- DLJCalibrators, Drug Specific
- KLTEnzyme Immunoassay, Carbamazepine
- KXTEnzyme Immunoassay, Digoxin
- LGJFluorescence Polarization Immunoassay, Amibacin
- LGRFluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
- LGQFluorescence Polarization Immunoassay, Phenobarbital
- LFWFluorescence Polarization Immunoassay, Tobramycin
- LCQFluorescent Immunoassay Gentamicin
- LERFluorescent Immunoassay, Theophylline
- JSXKit, Identification, Neisseria Gonorrhoeae
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