Modified Accufluor Gentamicin Reagent & Calibrator
FDA 510(k) K900703 · Innotron of Oregon, Inc.
510(k) numberK900703
Submission
- Device name
- Modified Accufluor Gentamicin Reagent & Calibrator
- Applicant
- Innotron of Oregon, Inc.
Portland, OR, US - Received
- February 12, 1990
- Decision date
- April 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K903101 | Innofluor (TM) Amikacin Calibrator SetDLJ · Traditional | 08/22/1990SE |
| K903100 | Innofluor (TM) Amikacin Reagent SetKLQ · Traditional | 08/09/1990SE |
| K900707 | Modified Accufluor Tobramycin Reagent & CalibratorLFW · Traditional | 04/20/1990SE |
| K900708 | Modified Accufluor Vancomycin Reagent & CalibratorLEH · Traditional | 04/19/1990SE |
| K900706 | Modified Accufluor Theophylline Reagent & CalibraLGS · Traditional | 04/12/1990SE |
| K900705 | Modified Accufluor Quinidine Reagent & CalibratorLBZ · Traditional | 04/12/1990SE |
| K900704 | Modified Accufluor Phenobarbital Reagent & CalibraLGQ · Traditional | 04/12/1990SE |
| K900702 | Modified Accufluor Carbamazepine Reagent & CalibraLGI · Traditional | 04/12/1990SE |
| K895827 | Innofluor Phenytoin Manual Fpia Reagent SetLGR · Traditional | 10/31/1989SE |
| K895828 | Innofluor Digoxin Reagent SetLCS · Traditional | 10/30/1989SE |
Questions and answers
When was Modified Accufluor Gentamicin Reagent & Calibrator cleared by the FDA?
Modified Accufluor Gentamicin Reagent & Calibrator (K900703) received a 510(k) decision of Substantially Equivalent on April 12, 1990, 59 days after the submission was received.
What is the product code of K900703?
The FDA product code is LCD – Enzyme Immunoassay, Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.