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510(k) K870752

Device
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
Applicant
MILES LABORATORIES, INC.
510(k) number
K870752
Product code
CFJ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-14
Date received
1987-02-25
Regulation
862.1440
Classification name
Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
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 CFJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2013-10-02
K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.2009-09-09
K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.2005-07-08
K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.1998-01-22
K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,1997-10-08
K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.1997-05-07
K971398LD-L REAGENTCarolina Liquid Chemistries Corp.1997-05-02
K964912LACTATE DEHYDROGENASEDerma Media Lab., Inc.1997-01-09
K961431LACTATE DEHYDROGENASE REAGENT SETPointe Scientific, Inc.,1996-06-03
K952747LACTATE DEHYDROGENASE REAGENT SYSTEMMedical Diagnostic Technologies, Inc.1995-08-07
K946022HICHEM LDH/L REAGENT KITHichem Diagnostics1995-02-23
K942964LACTATE DEHYDROGENASE QVETPrisma Systems1994-12-29
K935175LACTATE DEHYDROGENASE (LD)Em Diagnostic Systems, Inc.1993-12-16
K924703LACTATE DEHYDROGENASE (LD) TEST ITEM #65418Em Diagnostic Systems, Inc.1993-02-05
K924965OLYMPUS LACTATE DEHYDROGENASE REAGENTOlympus Corp.1992-11-16

Legacy Summary#

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FDA Review#

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