Modified Accufluor Tobramycin Reagent & Calibrator
FDA 510(k) K900707 · Innotron of Oregon, Inc.
510(k) numberK900707
Submission
- Device name
- Modified Accufluor Tobramycin Reagent & Calibrator
- Applicant
- Innotron of Oregon, Inc.
Portland, OR, US - Received
- February 12, 1990
- Decision date
- April 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFW – Fluorescence Polarization Immunoassay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964670 | Roche Cobas-Fp Reagents for TobramycinLFW · Traditional | Roche Diagnostic Systems, Inc. | 02/04/1997SE |
| K944371 | Tobramycin Fpia Reagent Set and CalibratorLFW · Traditional | Sigma Diagnostics, Inc. | 11/10/1994SE |
| K941614 | Axsym TobramycinLFW · Traditional | Abbott Laboratories | 08/18/1994SE |
| K912143 | Cedia(R) Tobramycin AssayLFW · Traditional | Microgenics Corp. | 07/26/1991SE |
| K894531 | FPR Tobramycin KitLFW · Traditional | Colony Laboratories, Inc. | 09/01/1989SE |
| K872562 | Innotron Innofluor Tobramycin Reagent SetLFW · Traditional | Innotron of Oregon, Inc. | 08/17/1987SE |
| K854392 | Tobramycin Kit(Fpia)Fluorescence Polarization ImmuLFW · Traditional | Windsor Laboratories, Inc. | 12/05/1985SE |
| K843828 | Cobas Reagents for Tobramycin & CalibraLFW · Traditional | Roche Diagnostic Systems, Inc. | 02/01/1985SE |
| K841866 | Innoflour TobramycinLFW · Traditional | Innotron Diagnostics | 05/31/1984SE |
More from Innotron Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K903101 | Innofluor (TM) Amikacin Calibrator SetDLJ · Traditional | 08/22/1990SE |
| K903100 | Innofluor (TM) Amikacin Reagent SetKLQ · Traditional | 08/09/1990SE |
| 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 |
| K900703 | Modified Accufluor Gentamicin Reagent & CalibratorLCD · 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 Tobramycin Reagent & Calibrator cleared by the FDA?
Modified Accufluor Tobramycin Reagent & Calibrator (K900707) received a 510(k) decision of Substantially Equivalent on April 20, 1990, 67 days after the submission was received.
What is the product code of K900707?
The FDA product code is LFW – Fluorescence Polarization Immunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.