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510(k) K842915

Device
SULFOSALICYLIC ACID, 3% W/V
Applicant
E K IND., INC.
510(k) number
K842915
Product code
JIQ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-10
Date received
1984-07-25
Regulation
862.1645
Classification name
Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JIQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141925TOTAL PROTEIN URINE/CSF GEN.3Roche Diagnostics Operations (Rdo)2014-12-09
K013643AUSAM TOTAL ALBUMIN ASSAYAusam Biotecthnologies, Inc.2003-08-14
K991800HEMOCHEK URINE COLLECTION KITOsborn Group, Inc.1999-09-24
K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITDiagnostic Specialties1997-09-02
K965035IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENTBeckman Instruments, Inc.1997-04-17
K944664WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATORWako Chemicals USA, Inc.1995-02-07
K936202URINARY ALBUMIN TEST PACKDupont Medical Products1994-05-09
K935662SYNERMED IR 500 CHEMISTRY ANALYZERSynermed, Inc.1994-04-26
K903123RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENTReagents Applications, Inc.1990-09-14
K902216WAKO(TM) MICRO-ALBUMINWako Chemicals USA, Inc.1990-06-18
K895883BECKMAN MA MICROALBUMIN REAGENT KITBeckman Instruments, Inc.1989-12-27
K870516ALBUMIN SCREEN TESTSclavo, Inc.1987-10-20

Legacy Summary#

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FDA Review#

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