Endab Phenobarbital
FDA 510(k) K852995 · Immunotech Corp.
510(k) numberK852995
Submission
- Device name
- Endab Phenobarbital
- Applicant
- Immunotech Corp.
Boston, MA, US - Received
- July 15, 1985
- Decision date
- August 12, 1985
- 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 |
|---|---|---|
| K954188 | Opticlone IGG1 FITC/IGG2A Pe Isotypic ControlGKZ · Traditional | 11/03/1995SE |
| K946335 | Opticlone(Tm CD3 FITC/CD19 Pe Monoclonal AntibodiesGKZ · Traditional | 10/20/1995SE |
| K953498 | Opticlone IGG1 FITC/IGG1 Pe Isotypic ControlGKZ · Traditional | 09/08/1995SE |
| K952789 | Opticlone CD4FITC/CD8 Pe Monoclonal AntibodiesGKZ · Traditional | 08/14/1995SE |
| K952182 | Opticlone CD3/CD8 Monoclonal AntibodiesGKZ · Traditional | 07/05/1995SE |
| K950626 | Opticlone CD3/CD4 Monoclonal AntibodiesGKZ · Traditional | 05/05/1995SE |
| K931228 | Progesterone Radioimmunoassay KitJLS · Traditional | 10/22/1993SE |
| K911634 | Microzyme(Tm) Free T4 Enzyme Immunoassay TestCEC · Traditional | 06/24/1991SE |
| K911153 | Microzyme Phencyclidine Enzyme Immunoassay Test KTLCM · Traditional | 06/18/1991SE |
| K910411 | Microzyme TSH Enzyme Immunoassay KitJLW · Traditional | 04/03/1991SE |
Questions and answers
When was Endab Phenobarbital cleared by the FDA?
Endab Phenobarbital (K852995) received a 510(k) decision of Substantially Equivalent on August 12, 1985, 28 days after the submission was received.
What is the product code of K852995?
The FDA product code is DLZ – Enzyme Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.