Product code DLZ
- Device name
- Enzyme Immunoassay, Phenobarbital
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3660
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210858 | VITROS Chemistry Products PHBR Slides | Ortho-Clinical Diagnostics, Inc. | 2021-08-13 |
| K123271 | ABBOTT PHENOBARBITAL ASSAY | Microgenics Corp. | 2013-04-26 |
| K081231 | ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 | Abbott Laboratories | 2008-09-26 |
| K071644 | ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 | Roche Diagnostics Corp. | 2007-09-12 |
| K011303 | RANDOX PHENOBARBITAL | Randox Laboratories, Ltd. | 2001-07-02 |
| K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | Syva Co. | 2001-06-06 |
| K000012 | IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 | Diagnostic Products Corp. | 2000-03-03 |
| K993031 | ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 | Syva Co. | 2000-01-27 |
| K984288 | VITROS CHEMISTRY PRODUCTS PHBR SLIDES | Ortho-Clinical Diagnostics, Inc. | 1999-01-26 |
| K946210 | PHENOBARBITAL ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1995-02-10 |
| K943981 | IL TEST PHENOBARBITAL CALIBRATORS | Instrumentation Laboratory CO | 1995-01-18 |
| K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE | Dupont Medical Products | 1994-12-28 |
| K942501 | ACE CEDIA PHENOBARBITAL ASSAY | Schiapparelli Biosystems, Inc. | 1994-10-06 |
| K935568 | PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS | Baxter Diagnostics, Inc. | 1994-03-11 |
| K913190 | EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS | Syva Co. | 1991-08-26 |
| K910355 | IL PHENOBARBITAL ASSAY SYSTEM | Instrumentation Laboratory CO | 1991-04-03 |
| K896861 | OPUS PHENOBARBITAL TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-01-11 |
| K884419 | TECHNICON RA-PHENOBARBITAL | Technicon Instruments Corp. | 1988-11-22 |
| K874625 | EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY | Syva Co. | 1987-12-22 |
| K864926 | EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 | Em Diagnostic Systems, Inc. | 1987-01-07 |
| K854607 | ACCULEVEL PHENOBARBITAL TEST | Syva Co. | 1986-08-25 |
| K862308 | EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 | Em Diagnostic Systems, Inc. | 1986-07-07 |
| K860365 | PHENOBARBITAL TEST SYSTEM | Allied Instrumentation Laboratory | 1986-03-17 |
| K860046 | DETERMINATION OF PHENOBARBITAL | Clinical Data, Inc. | 1986-01-22 |
| K852946 | SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT | Miles Laboratories, Inc. | 1985-09-30 |
| K852995 | ENDAB PHENOBARBITAL | Immunotech Corp. | 1985-08-12 |
| K842264 | VENTREZYME PHENOBARBITAL KIT IMMUNO | Ventrex Laboratories, Inc. | 1984-08-14 |
| K833796 | CHEM KIT PHENOBARBITAL | Abbott Laboratories | 1984-01-30 |
| K834216 | EMIT QST PHENOBARBITAL ASSAY | Syva Co. | 1984-01-24 |
| K832457 | A-GENT PHENOBARBITAL | Abbott Laboratories | 1983-09-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10758750004560 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2021-11-08 |
| 07613336121467 | ONLINE TDM Phenobarbital | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740154110 | Alinity | ABBOTT LABORATORIES | 2018-11-12 |
| 00630414595993 | Atellica CH Phnb | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 00842768017407 | Syva® Emit® 2000 Phenobarbital Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414964379 | IMMULITE®/IMMULITE® 1000 Systems PHE Phenobarbital | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414961828 | IMMULITE® 2000 Systems PHE Phenobarbital | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414561929 | ADVIA® Chemistry PHNB_2 Phenobarbital_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414527215 | ADVIA Centaur® Systems Phenobarbital Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414527208 | ADVIA Centaur® Systems, ACS:180® Systems PHNB Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414527192 | ADVIA Centaur® PHNB | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023224 | Emit® 2000 Phenobarbital Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768017414 | Syva® Emit® 2000 Phenobarbital Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015397 | Dimension Vista® Flex® reagent cartridge PHNO | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005596 | Dimension® Flex® reagent cartridge PHNO | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05055273206401 | PHB | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 04015630999323 | Phenobarbital | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630999316 | Phenobarbital | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630997060 | ONLINE TDM Phenobarbital | Roche Diagnostics GmbH | 2016-09-20 |
| 00884883001237 | CEDIA Phenobarbital II Assay | Microgenics Corporation | 2016-09-12 |
| 00380740001773 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740102692 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001780 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |