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510(k) K873366

Device
WAKO(TM) PRETEST 5A
Applicant
WAKO CHEMICALS, USA, INC.
510(k) number
K873366
Product code
CDM  
Decision
Substantially Equivalent (SESE)
Decision date
1988-01-21
Date received
1987-08-21
Regulation
862.1785
Classification name
Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TOSHIHIKO ODA
Address
12300 Ford Rd. Suite 130 Dallas TX US 75234 75234

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CDM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052719URITEST 10 URINALYSIS REAGENT STRIPSArj Medical, Inc.2006-12-05
K061559ACON URINALYSIS REAGENT STRIPSAcon Laboratories Co.2006-08-11
K880584URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8CMach Diag. C/O Wichita State University1988-05-31
K852611TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINEMiles Laboratories, Inc.1985-09-03
K821799FITKIT I CHECKUP KITPatton, Boggs & Blow1983-08-16
K830340FITKIT I CHECKUP KITBoditestor1983-08-16
K831623DIA STRIPS SYSTEMCalifornia Immuno Diagnostic, Inc.1983-07-28
K790965REAGENT STRIPS FOR URINALYSISMiles Laboratories, Inc.1979-06-28

Legacy Summary#

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FDA Review#

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