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510(k) K961588

Device
TOTAL IRON (NITRO-PAPS) REAGENT SET
Applicant
POINTE SCIENTIFIC, INC.
510(k) number
K961588
Product code
JIY  
Decision
Substantially Equivalent (SESE)
Decision date
1996-11-18
Date received
1996-04-24
Regulation
862.1410
Classification name
Photometric Method, Iron (non-heme)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM F WALTERS
Address
1025 John A. Papalas Dr. Lincoln Park MI US 48146 48146

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JIY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.2006-08-07
K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.2006-03-08
K051115SENTINEL IRON LIQUIDSentinel Ch. Srl2005-08-25
K033983VITALAB IRON REAGENTClinical Data, Inc.2004-05-21
K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical Data2003-06-17
K020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.2002-05-14
K013097WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003Wiener Laboratories Saic2001-11-13
K981241IRONAbbott Laboratories1998-05-01
K973933SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30Diagnostic Chemicals , Ltd.1997-11-04
K972363IL TEST IRONInstrumentation Laboratory CO1997-08-15
K964913IRON REAGENTDerma Media Lab., Inc.1997-02-20
K935712IRON/TIBC REAGENTHorizon Diagnostics, Inc.1995-09-20
K944911ACE IRON REAGENTSchiapparelli Biosystems, Inc.1995-02-10
K943029IRON QVETPrisma Systems1994-12-02
K944462DMA IRON PROCEDUREData Medical Associates, Inc.1994-11-15

Legacy Summary#

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FDA Review#

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