Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33
FDA 510(k) K081231 · Abbott Laboratories
510(k) numberK081231
Submission
- Device name
- Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- May 1, 2008
- Decision date
- September 26, 2008
- 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 |
| K123271 | Abbott Phenobarbital AssayDLZ · Traditional | Microgenics Corp. | 04/26/2013SE |
| 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 Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33 cleared by the FDA?
Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33 (K081231) received a 510(k) decision of Substantially Equivalent on September 26, 2008, 148 days after the submission was received.
What is the product code of K081231?
The FDA product code is DLZ – Enzyme Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.