QMS Amikacin Reagents
FDA 510(k) K052815 · Seradyn, Inc.
510(k) numberK052815
Submission
- Device name
- QMS Amikacin Reagents
- Applicant
- Seradyn, Inc.
Indianapolis, IN, US - Received
- October 4, 2005
- Decision date
- November 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K841161 | Immpulse Amikacin Assay ReagentsKLQ · Traditional | Paragon Diagnostics, Inc. | 05/02/1984SE |
| 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 |
|---|---|---|
| K070645 | Seradyn QMS TopiramateNWM · Traditional | 05/17/2007SE |
| K062966 | QMS Lamotrigine Assay (Reagents), Calibrators & ControlsORH · Traditional | 01/12/2007SE |
| K062204 | Architect Cortisol AssayJFT · Traditional | 09/22/2006SE |
| K060998 | QMS TobramycinLCR · Traditional | 07/21/2006SE |
| K060709 | Multigent GentamicinLCD · Traditional | 06/15/2006SE |
| K052826 | QMS Quinidine. QMS Quinidine CalibratorsLBZ · Traditional | 12/23/2005SE |
| K051211 | QMS Zonisamide Reagents, Calibrators and ControlsNWM · Traditional | 11/18/2005SE |
| K050419 | QMS VancomycinLEH · Traditional | 04/01/2005SE |
| K042307 | Architect T-Uptake Calibrators (A-F) and Controls (Low, High)JIT · Abbreviated | 11/03/2004SE |
| K033674 | Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C ControlsLCP · Traditional | 02/09/2004SE |
Questions and answers
When was QMS Amikacin Reagents cleared by the FDA?
QMS Amikacin Reagents (K052815) received a 510(k) decision of Substantially Equivalent on November 1, 2005, 28 days after the submission was received.
What is the product code of K052815?
The FDA product code is KLQ – Radioimmunoassay, Amikacin, a Class II (moderate risk) device regulated under 21 CFR 862.3035.