CEDIA(R) TOBRAMYCIN ASSAY
FDA 510(k) clearance K912143 · decided 1991-07-26
Clearance details
- K-number
- K912143
- Device name
- CEDIA(R) TOBRAMYCIN ASSAY
- Applicant
- Microgenics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-15
- Decision date
- 1991-07-26
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LFW
- Device class
- 2
- Regulation number
- 862.3900
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Concord, CA, 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 |
|---|---|---|
| ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (K964670) | Roche Diagnostic Systems, Inc. | 1997-02-04 |
| TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR (K944371) | Sigma Diagnostics, Inc. | 1994-11-10 |
| AXSYM TOBRAMYCIN (K941614) | Abbott Laboratories | 1994-08-18 |
| MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (K900707) | Innotron of Oregon, Inc. | 1990-04-20 |
| FPR TOBRAMYCIN KIT (K894531) | Colony Laboratories, Inc. | 1989-09-01 |
| INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET (K872562) | Innotron of Oregon, Inc. | 1987-08-17 |
| TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU (K854392) | Windsor Laboratories, Inc. | 1985-12-05 |
| COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA (K843828) | Roche Diagnostic Systems, Inc. | 1985-02-01 |
| INNOFLOUR TOBRAMYCIN (K841866) | Innotron Diagnostics | 1984-05-31 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 10001 recall (Z-0513-2014) | Microgenics Corp | 2013-12-16 |
| Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216. recall (Z-0574-06) | Roche Diagnostics Corp. | 2006-02-28 |