FDA.reportPublic FDA data

510(k) K864926

Device
Emds Tm Phenobarbital(phno) Testpack, #67677/95
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
510(k) number
K864926
Product code
DLZ
Decision
Substantially Equivalent (SESE)
Decision date
1987-01-07
Date received
1986-12-16
Regulation
862.3660
Classification name
Enzyme Immunoassay, Phenobarbital
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND L MILLER
Address
480 Democrat Rd. Gibbstown NJ US 08027 08027

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DLZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.2021-08-13
K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.2013-04-26
K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott Laboratories2008-09-26
K071644ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.2007-09-12
K011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.2001-07-02
K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.2001-06-06
K000012IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5Diagnostic Products Corp.2000-03-03
K993031ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54Syva Co.2000-01-27
K984288VITROS CHEMISTRY PRODUCTS PHBR SLIDESOrtho-Clinical Diagnostics, Inc.1999-01-26
K946210PHENOBARBITAL ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.1995-02-10
K943981IL TEST PHENOBARBITAL CALIBRATORSInstrumentation Laboratory CO1995-01-18
K944932PHENOBARBITAL FLEX REAGENT CARTRIDGEDupont Medical Products1994-12-28
K942501ACE CEDIA PHENOBARBITAL ASSAYSchiapparelli Biosystems, Inc.1994-10-06
K935568PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORSBaxter Diagnostics, Inc.1994-03-11
K913190EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORSSyva Co.1991-08-26