QMS Gentamicin Assay
FDA 510(k) K940376 · Seradyn, Inc.
510(k) numberK940376
Submission
- Device name
- QMS Gentamicin Assay
- Applicant
- Seradyn, Inc.
Indianapolis, IN, US - Received
- January 26, 1994
- Decision date
- June 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCD – Enzyme Immunoassay, Gentamicin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LCD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243500 | ARCHITECT iGentamicinLCD · Special | Abbott Laboratories | 07/09/2025SE |
| K102699 | Architect Igentamicin Reagents; Architect Igentamicin CalibratorsLCD · Traditional | Abbott Laboratories | 04/01/2011SE |
| K060709 | Multigent GentamicinLCD · Traditional | Seradyn, Inc. | 06/15/2006SE |
| K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…LCD · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/06/2005SE |
| K020704 | Roche Online GentamicinLCD · Traditional | Roche Diagnostics Corp. | 07/12/2002SE |
| K012978 | Randox GentamicinLCD · Traditional | Randox Laboratories, Ltd. | 09/18/2001SE |
| K012311 | Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)LCD · Traditional | Diagnostic Products Corp. | 08/20/2001SE |
| K010984 | Emit 2000 Gentamicin Plus AssayLCD · Special | Syva Co., Dade Behring, Inc. | 04/20/2001SE |
| K962819 | Gentamicin Flex Reagent CartridgeLCD · Traditional | Dade Intl., Inc. | 09/13/1996SE |
| K962519 | Emit 2000 Gentamicin Assay and CalibratorsLCD · Traditional | Behring Diagnostics, Inc. | 09/04/1996SE |
More from Behring Diagnostics, 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 |
| K052815 | QMS Amikacin ReagentsKLQ · Traditional | 11/01/2005SE |
| K050419 | QMS VancomycinLEH · Traditional | 04/01/2005SE |
| K042307 | Architect T-Uptake Calibrators (A-F) and Controls (Low, High)JIT · Abbreviated | 11/03/2004SE |
Questions and answers
When was QMS Gentamicin Assay cleared by the FDA?
QMS Gentamicin Assay (K940376) received a 510(k) decision of Substantially Equivalent on June 2, 1994, 127 days after the submission was received.
What is the product code of K940376?
The FDA product code is LCD – Enzyme Immunoassay, Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.