Innofluor Phenobarbital Assay System
FDA 510(k) K972330 · Oxis Intl., Inc.
510(k) numberK972330
Submission
- Device name
- Innofluor Phenobarbital Assay System
- Applicant
- Oxis Intl., Inc.
Portland, OR, US - Received
- June 23, 1997
- Decision date
- July 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K900704 | Modified Accufluor Phenobarbital Reagent & CalibraLGQ · Traditional | Innotron of Oregon, Inc. | 04/12/1990SE |
| 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 |
|---|---|---|
| K972331 | Innofluor Gentamicin Assay SystemLGQ · Traditional | 08/01/1997SE |
| K970517 | Innofluor Topiramate Control SetLAS · Traditional | 05/12/1997SE |
| K970510 | Innoflour Topiramate Reagent SetMSL · Traditional | 05/12/1997SE |
| K970509 | Innoflour Calibrator Reagent SetDLJ · Traditional | 05/12/1997SE |
| K955568 | Innofluor Quinidine Assay SystemLBZ · Traditional | 04/04/1996SE |
| K955570 | Innofluor Amikacin Assay SystemKLQ · Traditional | 02/09/1996SE |
| K955569 | Innofluor Gentamicin Assay SystemLCQ · Traditional | 02/09/1996SE |
| K955567 | Innofluor Theophylline Assay SystemLGS · Traditional | 01/24/1996SE |
| K955562 | Innofluor Phenytoin Assay SystemLGR · Traditional | 01/24/1996SE |
| K950346 | B-L Red(Tm) DiscsJTO · Traditional | 05/05/1995SE |
Questions and answers
When was Innofluor Phenobarbital Assay System cleared by the FDA?
Innofluor Phenobarbital Assay System (K972330) received a 510(k) decision of Substantially Equivalent on July 14, 1997, 21 days after the submission was received.
What is the product code of K972330?
The FDA product code is LGQ – Fluorescence Polarization Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.