ClearanceBrief
Panels › Clinical Toxicology › Product code DLZ · Class 2

Enzyme Immunoassay, Phenobarbital

Regulation 862.3660

0510(k)s in 12 months (35 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
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Top companies in DLZ

Company510(k)sRecalls
Syva Co.80
Abbott Laboratories32
Ortho-Clinical Diagnostics, Inc.23
Siemens Healthcare Diagnostics, Inc.03
Em Diagnostic Systems, Inc.20
Instrumentation Laboratory CO20
Allied Instrumentation Laboratory10
Baxter Diagnostics, Inc.10
Beckman Coulter Inc.01
Beckman Instruments, Inc.10
DateFirm and productCodeLinked 510(k)
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 25
Terminated		 DLZK984288
Nov 7, 2013Siemens Healthcare Diagnostics, Inc.
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Terminated		 DLZK011528
K913190
Apr 19, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Terminated		 DLZK984288
Apr 15, 2013Abbott Laboratories, Inc
Clinical Chemistry Phenobarbital, list number 1E08
Terminated		 DLZK993031
Jan 10, 2013Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human s
Terminated		 DLZK011528
K913190
Oct 10, 2012Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Terminated		 DLZK011528
K913190
Mar 6, 2012Beckman Coulter Inc.
Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CAL
Terminated		 DLZK955644
Feb 28, 2012Ortho-Clinical Diagnostics
VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wy
Terminated		 DLZK984288
Jan 9, 2007Abbott Laboratories Inc.
Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
Terminated		 DLZK993031

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