LGQ — Fluorescence Polarization Immunoassay, Phenobarbital Class II
FDA Device Classification
Classification Details
- Product Code
- LGQ
- Device Class
- Class II
- Regulation Number
- 862.3660
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K972331 | oxis intl | INNOFLUOR GENTAMICIN ASSAY SYSTEM | August 1, 1997 |
| K972330 | oxis intl | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM | July 14, 1997 |
| K940596 | abbott laboratories | AXSYM PHENOBARBITAL | June 21, 1994 |
| K936130 | roche diagnostic systems | COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS | March 11, 1994 |
| K900704 | innotron of oregon | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | April 12, 1990 |
| K894525 | colony laboratories | FPR PHENOBARBITAL KIT | August 28, 1989 |
| K872397 | roche diagnostic systems | COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. | July 21, 1987 |
| K863625 | windsor laboratories | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | November 10, 1986 |
| K862528 | sclavo | IMMPULSE PHENOBARBITAL ASSAY REAGENTS | July 16, 1986 |
| K854044 | abbott laboratories | TDX BARBITURATES | October 28, 1985 |
| K843825 | roche diagnostic systems | COBAS REAGENTS PHENOBARBITAL & PHENOBAR | February 1, 1985 |
| K841707 | innotron diagnostics | INNOFLUOR PHENOBARBITAL | May 23, 1984 |