Innofluor Gentamicin Assay System
FDA 510(k) K955569 · Oxis Intl., Inc.
510(k) numberK955569
Submission
- Device name
- Innofluor Gentamicin Assay System
- Applicant
- Oxis Intl., Inc.
Portland, OR, US - Received
- December 6, 1995
- Decision date
- February 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K852013 | Gentamicin Kit(Fpia)LCQ · Traditional | Windsor Laboratories, Inc. | 06/10/1985SE |
| 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 |
|---|---|---|
| K972331 | Innofluor Gentamicin Assay SystemLGQ · Traditional | 08/01/1997SE |
| K972330 | Innofluor Phenobarbital Assay SystemLGQ · Traditional | 07/14/1997SE |
| K970517 | Innofluor Topiramate Control SetLAS · Traditional | 05/12/1997SE |
| K970510 | Innoflour Topiramate Reagent SetMSL · Traditional | 05/12/1997SE |
| K970509 | Innoflour Calibrator Reagent SetDLJ · Traditional | 05/12/1997SE |
| K955568 | Innofluor Quinidine Assay SystemLBZ · Traditional | 04/04/1996SE |
| K955570 | Innofluor Amikacin Assay SystemKLQ · Traditional | 02/09/1996SE |
| K955567 | Innofluor Theophylline Assay SystemLGS · Traditional | 01/24/1996SE |
| K955562 | Innofluor Phenytoin Assay SystemLGR · Traditional | 01/24/1996SE |
| K950346 | B-L Red(Tm) DiscsJTO · Traditional | 05/05/1995SE |
Questions and answers
When was Innofluor Gentamicin Assay System cleared by the FDA?
Innofluor Gentamicin Assay System (K955569) received a 510(k) decision of Substantially Equivalent on February 9, 1996, 65 days after the submission was received.
What is the product code of K955569?
The FDA product code is LCQ – Fluorescent Immunoassay Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.