Modified Accufluor Phenobarbital Reagent & Calibra
FDA 510(k) K900704 · Innotron of Oregon, Inc.
510(k) numberK900704
Submission
- Device name
- Modified Accufluor Phenobarbital 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
- LGQ – Fluorescence Polarization Immunoassay, Phenobarbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3660
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LGQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972331 | Innofluor Gentamicin Assay SystemLGQ · Traditional | Oxis Intl., Inc. | 08/01/1997SE |
| K972330 | Innofluor Phenobarbital Assay SystemLGQ · Traditional | Oxis Intl., Inc. | 07/14/1997SE |
| K940596 | Axsym PhenobarbitalLGQ · Traditional | Abbott Laboratories | 06/21/1994SE |
| K936130 | Cobas-Fp Reagent for Phenobarbital and Cobas-Fp Phenobarbital CalibratorsLGQ · Traditional | Roche Diagnostic Systems, Inc. | 03/11/1994SE |
| K894525 | FPR Phenobarbital KitLGQ · Traditional | Colony Laboratories, Inc. | 08/28/1989SE |
| K872397 | Cobas FP Reagents for Pheno & Cobas FP Pheno Cali.LGQ · Traditional | Roche Diagnostic Systems, Inc. | 07/21/1987SE |
| K863625 | Phenobarbital-Fpia Fluores. Polar. Immunoassay KitLGQ · Traditional | Windsor Laboratories, Inc. | 11/10/1986SE |
| K862528 | Immpulse Phenobarbital Assay ReagentsLGQ · Traditional | Sclavo, Inc. | 07/16/1986SE |
| K854044 | TDX BarbituratesLGQ · Traditional | Abbott Laboratories | 10/28/1985SE |
| K843825 | Cobas Reagents Phenobarbital & PhenobarLGQ · Traditional | Roche Diagnostic Systems, Inc. | 02/01/1985SE |
More from Roche Diagnostic Systems, 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 |
| 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 Phenobarbital Reagent & Calibra cleared by the FDA?
Modified Accufluor Phenobarbital Reagent & Calibra (K900704) 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 K900704?
The FDA product code is LGQ – Fluorescence Polarization Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.