DLZ · Enzyme Immunoassay, Phenobarbital
Clinical Toxicology · 21 CFR 862.3660 · Class 2
Overview
| Product Code | DLZ |
|---|---|
| Device Name | Enzyme Immunoassay, Phenobarbital |
| Regulation | 21 CFR 862.3660 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210858 | VITROS Chemistry Products PHBR Slides | Ortho-Clinical Diagnostics, Inc. | Aug 13, 2021 | SESE |
| K123271 | ABBOTT PHENOBARBITAL ASSAY | Microgenics Corp. | Apr 26, 2013 | SESE |
| K081231 | ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 | Abbott Laboratories | Sep 26, 2008 | SESE |
| K071644 | ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 | Roche Diagnostics Corp. | Sep 12, 2007 | SESE |
| K011303 | RANDOX PHENOBARBITAL | Randox Laboratories, Ltd. | Jul 2, 2001 | SESE |
| K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | Syva Co. | Jun 6, 2001 | SESE |
| K000012 | IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 | Diagnostic Products Corp. | Mar 3, 2000 | SESE |
| K993031 | ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 | Syva Co. | Jan 27, 2000 | SESE |
| K984288 | VITROS CHEMISTRY PRODUCTS PHBR SLIDES | Ortho-Clinical Diagnostics, Inc. | Jan 26, 1999 | SESE |
| K946210 | PHENOBARBITAL ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | Feb 10, 1995 | SESE |
| K943981 | IL TEST PHENOBARBITAL CALIBRATORS | Instrumentation Laboratory CO | Jan 18, 1995 | SESE |
| K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE | Dupont Medical Products | Dec 28, 1994 | SESE |
| K942501 | ACE CEDIA PHENOBARBITAL ASSAY | Schiapparelli Biosystems, Inc. | Oct 6, 1994 | SESE |
| K935568 | PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS | Baxter Diagnostics, Inc. | Mar 11, 1994 | SESE |
| K913190 | EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS | Syva Co. | Aug 26, 1991 | SESE |
| K910355 | IL PHENOBARBITAL ASSAY SYSTEM | Instrumentation Laboratory CO | Apr 3, 1991 | SESE |
| K896861 | OPUS PHENOBARBITAL TEST SYSTEM | Pb Diagnostic Systems, Inc. | Jan 11, 1990 | SESE |
| K884419 | TECHNICON RA-PHENOBARBITAL | Technicon Instruments Corp. | Nov 22, 1988 | SESE |
| K874625 | EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY | Syva Co. | Dec 22, 1987 | SESE |
| K864926 | EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 | Em Diagnostic Systems, Inc. | Jan 7, 1987 | SESE |
Top Applicants
- Syva Co. — 8 clearances
- Abbott Laboratories — 3 clearances
- Em Diagnostic Systems, Inc. — 2 clearances
- Instrumentation Laboratory CO — 2 clearances
- Ortho-Clinical Diagnostics, Inc. — 2 clearances
