Immpulse Phenobarbital Assay Reagents
FDA 510(k) K862528 · Sclavo, Inc.
510(k) numberK862528
Submission
- Device name
- Immpulse Phenobarbital Assay Reagents
- Applicant
- Sclavo, Inc.
Sunnyvale, CA, US - Received
- July 2, 1986
- Decision date
- July 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K940596 | Axsym PhenobarbitalLGQ · Traditional | Abbott Laboratories | 06/21/1994SE |
| 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 |
| 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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| K880049 | Cholinesterase - Butyrythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
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Questions and answers
When was Immpulse Phenobarbital Assay Reagents cleared by the FDA?
Immpulse Phenobarbital Assay Reagents (K862528) received a 510(k) decision of Substantially Equivalent on July 16, 1986, 14 days after the submission was received.
What is the product code of K862528?
The FDA product code is LGQ – Fluorescence Polarization Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.