Roche Cobas-Fp Reagents for Tobramycin
FDA 510(k) K964670 · Roche Diagnostic Systems, Inc.
510(k) numberK964670
Submission
- Device name
- Roche Cobas-Fp Reagents for Tobramycin
- Applicant
- Roche Diagnostic Systems, Inc.
Somerville, NJ, US - Received
- November 21, 1996
- Decision date
- February 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFW – Fluorescence Polarization Immunoassay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944371 | Tobramycin Fpia Reagent Set and CalibratorLFW · Traditional | Sigma Diagnostics, Inc. | 11/10/1994SE |
| K941614 | Axsym TobramycinLFW · Traditional | Abbott Laboratories | 08/18/1994SE |
| K912143 | Cedia(R) Tobramycin AssayLFW · Traditional | Microgenics Corp. | 07/26/1991SE |
| K900707 | Modified Accufluor Tobramycin Reagent & CalibratorLFW · Traditional | Innotron of Oregon, Inc. | 04/20/1990SE |
| K894531 | FPR Tobramycin KitLFW · Traditional | Colony Laboratories, Inc. | 09/01/1989SE |
| K872562 | Innotron Innofluor Tobramycin Reagent SetLFW · Traditional | Innotron of Oregon, Inc. | 08/17/1987SE |
| K854392 | Tobramycin Kit(Fpia)Fluorescence Polarization ImmuLFW · Traditional | Windsor Laboratories, Inc. | 12/05/1985SE |
| K843828 | Cobas Reagents for Tobramycin & CalibraLFW · Traditional | Roche Diagnostic Systems, Inc. | 02/01/1985SE |
| K841866 | Innoflour TobramycinLFW · Traditional | Innotron Diagnostics | 05/31/1984SE |
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Questions and answers
When was Roche Cobas-Fp Reagents for Tobramycin cleared by the FDA?
Roche Cobas-Fp Reagents for Tobramycin (K964670) received a 510(k) decision of Substantially Equivalent on February 4, 1997, 75 days after the submission was received.
What is the product code of K964670?
The FDA product code is LFW – Fluorescence Polarization Immunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.