Immpulse Amikacin Assay Reagents
FDA 510(k) K841161 · Paragon Diagnostics, Inc.
510(k) numberK841161
Submission
- Device name
- Immpulse Amikacin 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
- KLQ – Radioimmunoassay, Amikacin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3035
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052815 | QMS Amikacin ReagentsKLQ · Traditional | Seradyn, Inc. | 11/01/2005SE |
| K033884 | Randox AmikacinKLQ · Traditional | Randox Laboratories, Ltd. | 06/09/2004SE |
| K955570 | Innofluor Amikacin Assay SystemKLQ · Traditional | Oxis Intl., Inc. | 02/09/1996SE |
| K903100 | Innofluor (TM) Amikacin Reagent SetKLQ · Traditional | Innotron of Oregon, Inc. | 08/09/1990SE |
| K894517 | FPR Amikacin KitKLQ · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K852317 | Cobas FP Reagen for Amikacin & Amikacin CalibratorKLQ · Traditional | Roche Diagnostic Systems, Inc. | 06/25/1985SE |
| K843211 | Amikacin Analytical Test Pack AcaKLQ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/12/1984SE |
| K840193 | Emit QST Amikacin AssayKLQ · Traditional | Syva Co. | 03/23/1984SE |
| K832336 | Stratus Amikacin FluorometricKLQ · Traditional | American Dade | 08/31/1983SE |
| K822657 | Emit-Amd Amikacin AssayKLQ · Traditional | Dade Behring, Inc. | 09/28/1982SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841162 | Immpulse Gentamicin Assay ReagentsLCQ · 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 Amikacin Assay Reagents cleared by the FDA?
Immpulse Amikacin Assay Reagents (K841161) 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 K841161?
The FDA product code is KLQ – Radioimmunoassay, Amikacin, a Class II (moderate risk) device regulated under 21 CFR 862.3035.