Phenobarbital Test System
FDA 510(k) K860365 · Allied Instrumentation Laboratory
510(k) numberK860365
Submission
- Device name
- Phenobarbital Test System
- Applicant
- Allied Instrumentation Laboratory
Lexington, MA, US - Received
- February 3, 1986
- Decision date
- March 17, 1986
- 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 |
More from Diagnostic Reagents, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861901 | MULTI-4 Co-Oximeter ControlJJY · Traditional | 06/17/1986SE |
| K860286 | Il Test PhenytoinDIP · Traditional | 03/05/1986SE |
| K853858 | Il Test Theophylline AssayKLS · Traditional | 10/15/1985SE |
| K852676 | Il System 1304 & 1306, Ph/Blood Gas AnalyzersCHL · Traditional | 07/22/1985SE |
| K851933 | Clinical Chemistry Analytical SystemJJF · Traditional | 06/10/1985SE |
| K850748 | I-L Test, Direct Bilirubin SetCIG · Traditional | 04/03/1985SE |
Questions and answers
When was Phenobarbital Test System cleared by the FDA?
Phenobarbital Test System (K860365) received a 510(k) decision of Substantially Equivalent on March 17, 1986, 42 days after the submission was received.
What is the product code of K860365?
The FDA product code is DLZ – Enzyme Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.