Cobas Reagents for Tobramycin & Calibra
FDA 510(k) K843828 · Roche Diagnostic Systems, Inc.
510(k) numberK843828
Submission
- Device name
- Cobas Reagents for Tobramycin & Calibra
- Applicant
- Roche Diagnostic Systems, Inc.
Mchenry, IL, US - Received
- September 28, 1984
- Decision date
- February 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K964670 | Roche Cobas-Fp Reagents for TobramycinLFW · Traditional | Roche Diagnostic Systems, Inc. | 02/04/1997SE |
| 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 |
| K841866 | Innoflour TobramycinLFW · Traditional | Innotron Diagnostics | 05/31/1984SE |
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Questions and answers
When was Cobas Reagents for Tobramycin & Calibra cleared by the FDA?
Cobas Reagents for Tobramycin & Calibra (K843828) received a 510(k) decision of Substantially Equivalent on February 1, 1985, 126 days after the submission was received.
What is the product code of K843828?
The FDA product code is LFW – Fluorescence Polarization Immunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.