LGQ
12 FDA 510(k) clearances · Product code
39 daysmedian time to decision
126 days90th percentile
12clearances measured
FDA profile
- Official device name
- Fluorescence Polarization Immunoassay, Phenobarbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3660
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| INNOFLUOR GENTAMICIN ASSAY SYSTEM (K972331) | Oxis Intl., Inc. | 1997-08-01 |
| INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (K972330) | Oxis Intl., Inc. | 1997-07-14 |
| AXSYM PHENOBARBITAL (K940596) | Abbott Laboratories | 1994-06-21 |
| COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (K936130) | Roche Diagnostic Systems, Inc. | 1994-03-11 |
| MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (K900704) | Innotron of Oregon, Inc. | 1990-04-12 |
| FPR PHENOBARBITAL KIT (K894525) | Colony Laboratories, Inc. | 1989-08-28 |
| COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. (K872397) | Roche Diagnostic Systems, Inc. | 1987-07-21 |
| PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT (K863625) | Windsor Laboratories, Inc. | 1986-11-10 |
| IMMPULSE PHENOBARBITAL ASSAY REAGENTS (K862528) | Sclavo, Inc. | 1986-07-16 |
| TDX BARBITURATES (K854044) | Abbott Laboratories | 1985-10-28 |
| COBAS REAGENTS PHENOBARBITAL & PHENOBAR (K843825) | Roche Diagnostic Systems, Inc. | 1985-02-01 |
| INNOFLUOR PHENOBARBITAL (K841707) | Innotron Diagnostics | 1984-05-23 |
Track LGQ automatically
Every clearance here is in the API, with alerts when new ones post.