LGR — Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) Class II
FDA Device Classification
Classification Details
- Product Code
- LGR
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K955873 | ciba corning diagnostics | ACS PHENYTOIN ASSAY | March 11, 1996 |
| K955562 | oxis intl | INNOFLUOR PHENYTOIN ASSAY SYSTEM | January 24, 1996 |
| K953840 | abbott laboratories | AXSYM PHENYTOIN II | September 25, 1995 |
| K946328 | abbott laboratories | TDX(R)/TDXFLX(R) PHENYTOIN II | March 28, 1995 |
| K943313 | sigma diagnostics | PHENYTOIN FPIA REAGENT SET AND CALIBRATORS | October 27, 1994 |
| K935375 | abbott laboratories | AXSYM PHENYTOIN ASSAY | June 21, 1994 |
| K936131 | roche diagnostic systems | COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS | March 11, 1994 |
| K896868 | pb diagnostic systems | OPUS PHENYTOIN TEST SYSTEM | January 2, 1990 |
| K895827 | innotron of oregon | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET | October 31, 1989 |
| K872563 | innotron of oregon | INNOTRON INNOFLUOR PHEYTOIN REAGENT SET | August 21, 1987 |
| K862554 | sclavo | IMMPULSE PHENYTOIN ASSAY REAGENT | July 16, 1986 |
| K843824 | roche diagnostic systems | COBAS FP REAGENTS FOR PHENYTOIN & CALIBR | February 1, 1985 |
| K844171 | bd becton dickinson vacutainer systems preanalytic | PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE | December 10, 1984 |
| K842586 | windsor laboratories | PHENYTOIN KIT FLUORESCENCE POLARIZATION | September 26, 1984 |
| K841706 | innotron diagnostics | INNOFLUOR PHENYTOIN | May 22, 1984 |