Immpulse Gentamicin Assay Reagents
FDA 510(k) K841162 · Paragon Diagnostics, Inc.
510(k) numberK841162
Submission
- Device name
- Immpulse Gentamicin Assay Reagents
- Applicant
- Paragon Diagnostics, Inc.
Mchenry, IL, US - Received
- March 19, 1984
- Decision date
- May 2, 1984
- 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 |
|---|---|---|
| K841161 | Immpulse Amikacin Assay ReagentsKLQ · Traditional | 05/02/1984SE |
| K840852 | Immpulse T4 Assay ReagentsCDX · Traditional | 04/18/1984SE |
| K840847 | Immpulse Tobramycin Assay ReagentsLCR · Traditional | 04/04/1984SE |
| K840758 | Immpulse Theophylline Assay ReagentsLER · Traditional | 04/04/1984SE |
| K840853 | Immpulse TBC Assay ReagentsKHQ · Traditional | 04/01/1984SE |
| K834070 | Immpulse SystemJZT · Traditional | 03/23/1984SE |
Questions and answers
When was Immpulse Gentamicin Assay Reagents cleared by the FDA?
Immpulse Gentamicin Assay Reagents (K841162) received a 510(k) decision of Substantially Equivalent on May 2, 1984, 44 days after the submission was received.
What is the product code of K841162?
The FDA product code is LCQ – Fluorescent Immunoassay Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.