Tdx(R)/Tdxflx(R) Phenytoin II
FDA 510(k) K946328 · Abbott Laboratories
510(k) numberK946328
Submission
- Device name
- Tdx(R)/Tdxflx(R) Phenytoin II
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- December 29, 1994
- Decision date
- March 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGR – Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LGR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955873 | Acs Phenytoin AssayLGR · Traditional | Ciba Corning Diagnostics Corp. | 03/11/1996SE |
| K955562 | Innofluor Phenytoin Assay SystemLGR · Traditional | Oxis Intl., Inc. | 01/24/1996SE |
| K953840 | Axsym Phenytoin IILGR · Traditional | Abbott Laboratories | 09/25/1995SE |
| K943313 | Phenytoin Fpia Reagent Set and CalibratorsLGR · Traditional | Sigma Diagnostics, Inc. | 10/27/1994SE |
| K935375 | Axsym Phenytoin AssayLGR · Traditional | Abbott Laboratories | 06/21/1994SE |
| K936131 | Cobas-Fp Reagent for Phenytoin and Coba-Fp Phenytoin CalibratorsLGR · Traditional | Roche Diagnostic Systems, Inc. | 03/11/1994SE |
| K896868 | Opus Phenytoin Test SystemLGR · Traditional | Pb Diagnostic Systems, Inc. | 01/02/1990SE |
| K895827 | Innofluor Phenytoin Manual Fpia Reagent SetLGR · Traditional | Innotron of Oregon, Inc. | 10/31/1989SE |
| K872563 | Innotron Innofluor Pheytoin Reagent SetLGR · Traditional | Innotron of Oregon, Inc. | 08/21/1987SE |
| K862554 | Immpulse Phenytoin Assay ReagentLGR · Traditional | Sclavo, Inc. | 07/16/1986SE |
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Questions and answers
When was Tdx(R)/Tdxflx(R) Phenytoin II cleared by the FDA?
Tdx(R)/Tdxflx(R) Phenytoin II (K946328) received a 510(k) decision of Substantially Equivalent on March 28, 1995, 89 days after the submission was received.
What is the product code of K946328?
The FDA product code is LGR – Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total), a Class II (moderate risk) device regulated under 21 CFR 862.3350.