COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
FDA 510(k) clearance K936130 · decided 1994-03-11
Clearance details
- K-number
- K936130
- Device name
- COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-23
- Decision date
- 1994-03-11
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LGQ
- Device class
- 2
- Regulation number
- 862.3660
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.