Axsym Tobramycin
FDA 510(k) K941614 · Abbott Laboratories
510(k) numberK941614
Submission
- Device name
- Axsym Tobramycin
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- April 4, 1994
- Decision date
- August 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Innotron Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
Questions and answers
When was Axsym Tobramycin cleared by the FDA?
Axsym Tobramycin (K941614) received a 510(k) decision of Substantially Equivalent on August 18, 1994, 136 days after the submission was received.
What is the product code of K941614?
The FDA product code is LFW – Fluorescence Polarization Immunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.