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510(k) K852946

Device
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
Applicant
MILES LABORATORIES, INC.
510(k) number
K852946
Product code
DLZ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-30
Date received
1985-07-11
Regulation
862.3660
Classification name
Enzyme Immunoassay, Phenobarbital
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN H ENGELMANN
Address
1127 Myrtle St. P.O. Box 40 Elkhart IN US 46514 46514

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

Legacy Summary#

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FDA Review#

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