Axsym Phenobarbital
FDA 510(k) K940596 · Abbott Laboratories
510(k) numberK940596
Submission
- Device name
- Axsym Phenobarbital
- Applicant
- Abbott Laboratories
Spartanburg, SC, US - Received
- February 10, 1994
- Decision date
- June 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGQ – Fluorescence Polarization Immunoassay, Phenobarbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3660
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LGQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972331 | Innofluor Gentamicin Assay SystemLGQ · Traditional | Oxis Intl., Inc. | 08/01/1997SE |
| K972330 | Innofluor Phenobarbital Assay SystemLGQ · Traditional | Oxis Intl., Inc. | 07/14/1997SE |
| K936130 | Cobas-Fp Reagent for Phenobarbital and Cobas-Fp Phenobarbital CalibratorsLGQ · Traditional | Roche Diagnostic Systems, Inc. | 03/11/1994SE |
| K900704 | Modified Accufluor Phenobarbital Reagent & CalibraLGQ · Traditional | Innotron of Oregon, Inc. | 04/12/1990SE |
| K894525 | FPR Phenobarbital KitLGQ · Traditional | Colony Laboratories, Inc. | 08/28/1989SE |
| K872397 | Cobas FP Reagents for Pheno & Cobas FP Pheno Cali.LGQ · Traditional | Roche Diagnostic Systems, Inc. | 07/21/1987SE |
| K863625 | Phenobarbital-Fpia Fluores. Polar. Immunoassay KitLGQ · Traditional | Windsor Laboratories, Inc. | 11/10/1986SE |
| K862528 | Immpulse Phenobarbital Assay ReagentsLGQ · Traditional | Sclavo, Inc. | 07/16/1986SE |
| K854044 | TDX BarbituratesLGQ · Traditional | Abbott Laboratories | 10/28/1985SE |
| K843825 | Cobas Reagents Phenobarbital & PhenobarLGQ · Traditional | Roche Diagnostic Systems, Inc. | 02/01/1985SE |
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Questions and answers
When was Axsym Phenobarbital cleared by the FDA?
Axsym Phenobarbital (K940596) received a 510(k) decision of Substantially Equivalent on June 21, 1994, 131 days after the submission was received.
What is the product code of K940596?
The FDA product code is LGQ – Fluorescence Polarization Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.