Axsym Theophylline II
FDA 510(k) K953016 · Abbott Laboratories
510(k) numberK953016
Submission
- Device name
- Axsym Theophylline II
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- June 29, 1995
- Decision date
- August 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGS – Fluorescence Polarization Immunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070810 | Architect I Theophylline Reagents and Calibrators (A-F)LGS · Traditional | Biokit, S.A. | 06/08/2007SE |
| K955567 | Innofluor Theophylline Assay SystemLGS · Traditional | Oxis Intl., Inc. | 01/24/1996SE |
| K951169 | Ciba Corining Acs Theophylline ImmunoassayLGS · Traditional | Ciba Corning Diagnostics Corp. | 06/20/1995SE |
| K942991 | QMS Theophylline CSLGS · Traditional | Seradyn, Inc. | 09/09/1994SE |
| K932127 | Tdx/Tdxflx & Tdxflx Theophylline Monoclonal IILGS · Traditional | Abbott Laboratories | 08/09/1993SE |
| K922991 | Abbott Tdx/Tdxflx and Tdxflx TheophyllineLGS · Traditional | Abbott Laboratories | 08/27/1992SE |
| K900706 | Modified Accufluor Theophylline Reagent & CalibraLGS · Traditional | Innotron of Oregon, Inc. | 04/12/1990SE |
| K894529 | FPR Theophylline KitLGS · Traditional | Colony Laboratories, Inc. | 09/15/1989SE |
| K871484 | Cobas FP Reagents for Theophylline & CalibratorsLGS · Traditional | Roche Diagnostic Systems, Inc. | 05/28/1987SE |
| K870277 | Monitorx Laserx Theophylline Reagent SetLGS · Traditional | American Monitor Corp. | 02/18/1987SE |
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Questions and answers
When was Axsym Theophylline II cleared by the FDA?
Axsym Theophylline II (K953016) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 56 days after the submission was received.
What is the product code of K953016?
The FDA product code is LGS – Fluorescence Polarization Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.