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510(k) K812574

Device
HDL CHOLESTEROL REAGENT
Applicant
POINTE SCIENTIFIC, INC.
510(k) number
K812574
Product code
LBR  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-24
Date received
1981-09-09
Regulation
862.1475
Classification name
Ldl & Vldl Precipitation, Hdl
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 LBR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143691LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (Rdo)2015-01-28
K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral Atomics2008-01-22
K050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco Diagnostics2005-07-26
K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERHemagen Diagnostics, Inc.2002-12-24
K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.2001-08-30
K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan Diagnostics1999-08-12
K992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, Inc.,1999-08-05
K991789ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan Holdings, Inc.1999-07-09
K990247MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470Polymer Technology Systems, Inc.1999-05-28
K984303VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENTOrtho-Clinical Diagnostics, Inc.1999-01-28
K980772HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51Diagnostic Chemicals , Ltd.1998-04-27
K980770HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51Diagnostic Chemicals , Ltd.1998-04-21
K974733BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROLBoehringer Mannheim Corp.1998-01-26
K973369ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)Roche Diagnostic Systems, Inc.1997-11-21
K971573N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SETGenzyme Corp.1997-06-18

Legacy Summary#

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FDA Review#

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