Cybrex Gentamicin
FDA 510(k) K801084 · Abbott Laboratories
510(k) numberK801084
Submission
- Device name
- Cybrex Gentamicin
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- May 7, 1980
- Decision date
- May 23, 1980
- 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 |
| 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 |
More from Roche Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
Questions and answers
When was Cybrex Gentamicin cleared by the FDA?
Cybrex Gentamicin (K801084) received a 510(k) decision of Substantially Equivalent on May 23, 1980, 16 days after the submission was received.
What is the product code of K801084?
The FDA product code is LCQ – Fluorescent Immunoassay Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.