Modified Accufluor Theophylline Reagent & Calibra
FDA 510(k) K900706 · Innotron of Oregon, Inc.
510(k) numberK900706
Submission
- Device name
- Modified Accufluor Theophylline Reagent & Calibra
- 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
- LGS – Fluorescence Polarization Immunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070810 | Architect I Theophylline Reagents and Calibrators (A-F)LGS · Traditional | Biokit, S.A. | 06/08/2007SE |
| K955567 | Innofluor Theophylline Assay SystemLGS · Traditional | Oxis Intl., Inc. | 01/24/1996SE |
| K953016 | Axsym Theophylline IILGS · Traditional | Abbott Laboratories | 08/24/1995SE |
| K951169 | Ciba Corining Acs Theophylline ImmunoassayLGS · Traditional | Ciba Corning Diagnostics Corp. | 06/20/1995SE |
| K942991 | QMS Theophylline CSLGS · Traditional | Seradyn, Inc. | 09/09/1994SE |
| K932127 | Tdx/Tdxflx & Tdxflx Theophylline Monoclonal IILGS · Traditional | Abbott Laboratories | 08/09/1993SE |
| K922991 | Abbott Tdx/Tdxflx and Tdxflx TheophyllineLGS · Traditional | Abbott Laboratories | 08/27/1992SE |
| K894529 | FPR Theophylline KitLGS · Traditional | Colony Laboratories, Inc. | 09/15/1989SE |
| K871484 | Cobas FP Reagents for Theophylline & CalibratorsLGS · Traditional | Roche Diagnostic Systems, Inc. | 05/28/1987SE |
| K870277 | Monitorx Laserx Theophylline Reagent SetLGS · Traditional | American Monitor Corp. | 02/18/1987SE |
More from American Monitor Corp.
| 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 |
| 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 Theophylline Reagent & Calibra cleared by the FDA?
Modified Accufluor Theophylline Reagent & Calibra (K900706) 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 K900706?
The FDA product code is LGS – Fluorescence Polarization Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.