LGQ — Fluorescence Polarization Immunoassay, Phenobarbital Class II
FDA product code LGQ covers "Fluorescence Polarization Immunoassay, Phenobarbital", a Class II medical device regulated under 21 CFR 862.3660. Submissions are reviewed by the Clinical Toxicology panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |