Phenobarbital Reagent Test Kit
FDA 510(k) K802039 · Beckman Instruments, Inc.
510(k) numberK802039
Submission
- Device name
- Phenobarbital Reagent Test Kit
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- August 25, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLZ – Enzyme Immunoassay, Phenobarbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3660
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210858 | VITROS Chemistry Products PHBR SlidesDLZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 08/13/2021SE |
| K123271 | Abbott Phenobarbital AssayDLZ · Traditional | Microgenics Corp. | 04/26/2013SE |
| K081231 | Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33…DLZ · Traditional | Abbott Laboratories | 09/26/2008SE |
| K071644 | Online Phenobarbital, Model 03016757190 & 03510620DLZ · Traditional | Roche Diagnostics Corp. | 09/12/2007SE |
| K011303 | Randox PhenobarbitalDLZ · Traditional | Randox Laboratories, Ltd. | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | Syva Co. | 06/06/2001SE |
| K000012 | Immulite Phenobarbital, Models LKPB1, LKPB5DLZ · Traditional | Diagnostic Products Corp. | 03/03/2000SE |
| K993031 | Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54DLZ · Traditional | Syva Co. | 01/27/2000SE |
| K984288 | Vitros Chemistry Products PHBR SlidesDLZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/26/1999SE |
| K946210 | Phenobarbital Enzyme ImmunoassayDLZ · Traditional | Diagnostic Reagents, Inc. | 02/10/1995SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Phenobarbital Reagent Test Kit cleared by the FDA?
Phenobarbital Reagent Test Kit (K802039) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 59 days after the submission was received.
What is the product code of K802039?
The FDA product code is DLZ – Enzyme Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.