LGR — Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) Class II
FDA product code LGR covers "Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)", a Class II medical device regulated under 21 CFR 862.3350. Submissions are reviewed by the Clinical Toxicology panel. At least 15 recent 510(k) clearances have been granted under this product code.
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 |