510(k) K936130
- Device
- COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K936130
- Product code
- LGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-11
- Date received
- 1993-12-23
- Regulation
- 862.3660
- Classification name
- Fluorescence Polarization Immunoassay, Phenobarbital
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL L KRIEGER
- Address
- 1080 Us Hwy. 202 Branchburg NJ US 08876 08876
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 |
| 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 |
| K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | Windsor Laboratories, Inc. | 1986-11-10 |
| 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases