Abbott Phenobarbital Assay
FDA 510(k) K123271 · Microgenics Corp.
510(k) numberK123271
Submission
- Device name
- Abbott Phenobarbital Assay
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- October 19, 2012
- Decision date
- April 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DLZ – Enzyme Immunoassay, Phenobarbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3660
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K210858 | VITROS Chemistry Products PHBR SlidesDLZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 08/13/2021SE |
| 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 |
| K943981 | Il Test Phenobarbital CalibratorsDLZ · Traditional | Instrumentation Laboratory CO | 01/18/1995SE |
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Questions and answers
When was Abbott Phenobarbital Assay cleared by the FDA?
Abbott Phenobarbital Assay (K123271) received a 510(k) decision of Substantially Equivalent on April 26, 2013, 189 days after the submission was received.
What is the product code of K123271?
The FDA product code is DLZ – Enzyme Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.