510(k) K863625
- Device
- PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT
- Applicant
- WINDSOR LABORATORIES, INC.
- 510(k) number
- K863625
- Product code
- LGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-10
- Date received
- 1986-09-17
- Regulation
- 862.3660
- Classification name
- Fluorescence Polarization Immunoassay, Phenobarbital
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GUY W RUCKER
- Address
- P.O. Box 475487 Garland TX US 75047 75047
FDA Registration Numbers#
- 3006198300
- 3003795116
- 9610126
- 9610529
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LGQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972331 | INNOFLUOR GENTAMICIN ASSAY SYSTEM | Oxis Intl., Inc. | 1997-08-01 |
| K972330 | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM | Oxis Intl., Inc. | 1997-07-14 |
| K940596 | AXSYM PHENOBARBITAL | Abbott Laboratories | 1994-06-21 |
| K936130 | COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS | Roche Diagnostic Systems, Inc. | 1994-03-11 |
| K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | Innotron of Oregon, Inc. | 1990-04-12 |
| K894525 | FPR PHENOBARBITAL KIT | Colony Laboratories, Inc. | 1989-08-28 |
| K872397 | COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. | Roche Diagnostic Systems, Inc. | 1987-07-21 |
| K862528 | IMMPULSE PHENOBARBITAL ASSAY REAGENTS | Sclavo, Inc. | 1986-07-16 |
| K854044 | TDX BARBITURATES | Abbott Laboratories | 1985-10-28 |
| K843825 | COBAS REAGENTS PHENOBARBITAL & PHENOBAR | Roche Diagnostic Systems, Inc. | 1985-02-01 |
| K841707 | INNOFLUOR PHENOBARBITAL | Innotron Diagnostics | 1984-05-23 |
Legacy Summary#
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FDA Review#
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