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510(k) K873304

Device
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
Applicant
MILES LABORATORIES, INC.
510(k) number
K873304
Product code
LJX  
Decision
Substantially Equivalent (SESE)
Decision date
1987-09-11
Date received
1987-08-18
Regulation
864.7675
Classification name
Test, Urine Leukocyte
Medical specialty
Hematology
Review panel
Hematology
Device class
1
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 LJX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231045Healgen URS Test StripsHealgen Scientific,, LLC2023-06-16
K063295ACON UTI URINARY TRACT INFECTION TEST STRIPSACON Laboratories, Inc.2007-10-12
K000578SERIM LEUKOCYTE ESTERASE TEST STRIPSSerim Research Corp.2000-05-05
K981555DIASCREEN REAGENT STRIPSChronimed, Inc.1998-06-01
K971976DIASCREEN REAGENT STRIPSDia-Screen Corp.1997-06-17
K843727LEUKOSTIX REAGENT STRIPS FOR URINALYSISMiles Laboratories, Inc.1985-01-04

Legacy Summary#

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FDA Review#

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