Gentamicin Kit(Fpia)
FDA 510(k) K852013 · Windsor Laboratories, Inc.
510(k) numberK852013
Submission
- Device name
- Gentamicin Kit(Fpia)
- Applicant
- Windsor Laboratories, Inc.
Garland, TX, US - Received
- May 9, 1985
- Decision date
- June 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCQ – Fluorescent Immunoassay Gentamicin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LCQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972609 | Variant Express Glycohemoglobin ProgramLCQ · Traditional | Bio-Rad | 08/06/1997SE |
| K955569 | Innofluor Gentamicin Assay SystemLCQ · Traditional | Oxis Intl., Inc. | 02/09/1996SE |
| K945523 | Cobas(R)-Fp Reagents for Gentamicin and Cobas(R)-Fp Gentamicin CalibratorsLCQ · Traditional | Roche Diagnostic Systems, Inc. | 03/09/1995SE |
| K943550 | Gentamicin Fpia Reagent Set and CalibratorsLCQ · Traditional | Sigma Diagnostics, Inc. | 11/17/1994SE |
| K905721 | Opus GentamicinLCQ · Traditional | Pb Diagnostic Systems, Inc. | 02/21/1991SE |
| K904226 | 'Tdxflx AnalyzerLCQ · Traditional | Abbott Laboratories | 10/29/1990SE |
| K894523 | FPR Gentamicin KitLCQ · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K852158 | Bioprobe Fluor Gentamicin in Serum or PlasmaLCQ · Traditional | Bioprobe Intl., Inc. | 06/25/1985SE |
| K843827 | Cobas Reagents for Gentamicin & CalibratLCQ · Traditional | Roche Diagnostic Systems, Inc. | 02/01/1985SE |
| K841865 | Innoflour GentamicinLCQ · Traditional | Innotron Diagnostics | 05/31/1984SE |
More from Innotron Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K873281 | Carbamazepine (Fpia) Calibrator KitDLJ · Traditional | 10/28/1987SE |
| K873282 | Carbamazepine Fpia Fluores. Polariza. ImmunoassayKLT · Traditional | 09/22/1987SE |
| K871486 | (Fpia) Assay BufferJJF · Traditional | 05/08/1987SE |
| K870390 | Phenobarbital (Fpia) Calibrator KitDLJ · Traditional | 04/01/1987SE |
| K870389 | Digoxin (Fpia) Calibrator KitDLJ · Traditional | 04/01/1987SE |
| K864333 | Digoxin Fpia Fluorescence Polarization ImmunoassayKXT · Traditional | 01/05/1987SE |
| K863625 | Phenobarbital-Fpia Fluores. Polar. Immunoassay KitLGQ · Traditional | 11/10/1986SE |
| K863244 | Amikacin (Fpia) Calibrator KitDLJ · Traditional | 08/29/1986SE |
| K862248 | Amikacin Kit (Fpia)LGJ · Traditional | 08/04/1986SE |
| K861891 | Tobramycin (Fpia) Calibrator KitJIS · Traditional | 06/25/1986SE |
Questions and answers
When was Gentamicin Kit(Fpia) cleared by the FDA?
Gentamicin Kit(Fpia) (K852013) received a 510(k) decision of Substantially Equivalent on June 10, 1985, 32 days after the submission was received.
What is the product code of K852013?
The FDA product code is LCQ – Fluorescent Immunoassay Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.