Innofluor Theophylline Assay System
FDA 510(k) K955567 · Oxis Intl., Inc.
510(k) numberK955567
Submission
- Device name
- Innofluor Theophylline Assay System
- Applicant
- Oxis Intl., Inc.
Portland, OR, US - Received
- December 6, 1995
- Decision date
- January 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K900706 | Modified Accufluor Theophylline Reagent & CalibraLGS · Traditional | Innotron of Oregon, Inc. | 04/12/1990SE |
| 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 |
|---|---|---|
| K972331 | Innofluor Gentamicin Assay SystemLGQ · Traditional | 08/01/1997SE |
| K972330 | Innofluor Phenobarbital Assay SystemLGQ · Traditional | 07/14/1997SE |
| 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 |
| 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 Theophylline Assay System cleared by the FDA?
Innofluor Theophylline Assay System (K955567) received a 510(k) decision of Substantially Equivalent on January 24, 1996, 49 days after the submission was received.
What is the product code of K955567?
The FDA product code is LGS – Fluorescence Polarization Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.