LGS — Fluorescence Polarization Immunoassay, Theophylline Class II
FDA product code LGS covers "Fluorescence Polarization Immunoassay, Theophylline", a Class II medical device regulated under 21 CFR 862.3880. Submissions are reviewed by the Clinical Toxicology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LGS
- Device Class
- Class II
- Regulation Number
- 862.3880
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070810 | biokit | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) | June 8, 2007 |
| K955567 | oxis intl | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM | January 24, 1996 |
| K953016 | abbott laboratories | AXSYM THEOPHYLLINE II | August 24, 1995 |
| K951169 | ciba corning diagnostics | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY | June 20, 1995 |
| K942991 | seradyn | QMS THEOPHYLLINE CS | September 9, 1994 |
| K932127 | abbott laboratories | TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II | August 9, 1993 |
| K922991 | abbott laboratories | ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE | August 27, 1992 |
| K900706 | innotron of oregon | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | April 12, 1990 |
| K894529 | colony laboratories | FPR THEOPHYLLINE KIT | September 15, 1989 |
| K871484 | roche diagnostic systems | COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS | May 28, 1987 |
| K870277 | american monitor | MONITORX LASERX THEOPHYLLINE REAGENT SET | February 18, 1987 |
| K850629 | innotron diagnostics | INNOFLUOR THEOPHYLLINE | March 12, 1985 |
| K843826 | roche diagnostic systems | COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL | February 1, 1985 |