Atlas FDA

LBR

66 FDA 510(k) clearances · Product code

59 daysmedian time to decision
137 days90th percentile
66clearances measured

FDA profile

Official device name
Ldl & Vldl Precipitation, Hdl
Device class
Class I (low risk)
Regulation
21 CFR 862.1475
Medical specialty
Clinical Chemistry
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RecordFirmDate
LDLC3 LDL-Cholesterol Gen.3 (K143691)Roche Diagnostics Operations (Rdo)2015-01-28
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (K072523)General Atomics2008-01-22
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (K050823)Teco Diagnostics2005-07-26
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER (K023784)Hemagen Diagnostics, Inc.2002-12-24
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K012593)Ortho-Clinical Diagnostics, Inc.2001-08-30
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K992029)Elan Diagnostics1999-08-12
AUTOHDL CHOLESTEROL REAGENT SET (K992002)Pointe Scientific, Inc.,1999-08-05
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K991789)Elan Holdings, Inc.1999-07-09
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (K990247)Polymer Technology Systems, Inc.1999-05-28
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (K984303)Ortho-Clinical Diagnostics, Inc.1999-01-28
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (K980772)Diagnostic Chemicals , Ltd.1998-04-27
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 (K980770)Diagnostic Chemicals , Ltd.1998-04-21
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL (K974733)Boehringer Mannheim Corp.1998-01-26
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) (K973369)Roche Diagnostic Systems, Inc.1997-11-21
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K971573)Genzyme Corp.1997-06-18
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN (K962723)Trace America, Inc.1997-03-13
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K962186)Genzyme Corp.1996-08-19
HDL PRECIPITATING REAGENT (K954179)Schiapparelli Biosystems, Inc.1995-12-11
MAGNETIC HDL CHOLESTEROL TEST (K944975)Reference Diagnostics, Inc.1995-08-02
PBI PLUS HDL PRECIPITATING REAGENT (K941744)Merchant House Scientific1994-09-06
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) (K932766)Diagnostic Chemicals, Ltd. (Usa)1993-12-10
SPINPRO HDL PRECIPITATING REAGENT (K934961)Merchant House Scientific1993-12-09
SPINPRO HDL PRECIPITATING REAGENT (K934801)Merchant House Scientific1993-12-07
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET (K934039)Intersect Systems, Inc.1993-11-16
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (K931773)King Diagnostics, Inc.1993-08-16
SYNERMED HDL CHOLESTLEROL REAGENT KIT (K924427)Synermed, Inc.1992-11-09
IL TEST(TM) HDL CHOLESTEROL (K914811)Instrumentation Laboratory CO1992-01-09
HIGH DENSITY LIPOPROTEIN CHOLESTEROL (K912823)Creative Laboratory Products, Inc.1991-08-16
MAGNETIC HDL CHOLESTEROL TEST (K911906)Reference Diagnostics, Inc.1991-07-18
HDL CHOLESTEROL REAGENT (K911406)Genzyme Corp.1991-05-22
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM (K903733)Institute For Clinical Applications1991-01-15
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 (K905284)Amresco, Inc.1990-12-11
BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT (K904184)Biotron U.S.A., Inc.1990-11-28
STAT TEST HDL/CHOLESTEROL TEST KIT (K903094)Diagnostic Resources, Inc.1990-08-29
REFLOTRON HDL CHOLESTEROL TEST TABS (K902568)Boehringer Mannheim Corp.1990-08-09
COULTER HDL - CHOLESTEROL REAGENT (K902174)Coulter Corp.1990-07-31
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL (K900120)Roche Diagnostic Systems, Inc.1990-03-09
HDL SINGLES (K895381)Trace America, Inc.1989-11-08
HDL PRECIPITATING REAGENT (K893966)Diagnostic Systems1989-07-25
HDL CHOLESTEROL REAGENT (K891117)Pointe Scientific, Inc.,1989-04-10
STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE (K890669)Norfolk Scientific, Inc.1989-03-08
HDL CHOLESTEROL REAGENT (PTA/MGCL2) (K890023)Sigma Diagnostics, Inc.1989-02-17
HDL CHOLESTEROL TEST (K885265)Em Diagnostic Systems, Inc.1989-02-10
IQ HDL CHOLESTEROL (K883353)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-13
CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES (K882488)Canyon Diagnostics, Inc.1988-08-15
HDL CHOLESTEROL KIT (K881244)Trace Scientific , Ltd.1988-06-10
HDL CHOLESTEROL PRECIPITATING PROCEDURE (K881326)Data Medical Associates, Inc.1988-05-27
HDL CHOLESTEROL PRECIPITATING REAGENT (K880176)Tech-Co, Inc.1988-02-18
MULTICHEM HDL PRECIPITATING REAGENT #S0914 (K874820)Simmler, Inc.1988-01-07
WORTHINGTON HDL PRECIPITATING REAGENT SET (K861926)Cooper Biomedical, Inc.1986-06-27
HDL CHOLESTEROL PRETREATMENT (K852350)American Monitor Corp.1985-07-08
HDL PRECIPATATING REAGENT SET (K843894)Livonia Diagnostics, Inc.1984-11-02
HDL CHOLESTEROL PRETREATMENT (K834251)American Monitor Corp.1984-02-13
HDL EZ-TAB (K833160)Preventive Diagnostics Corp.1984-02-09
HDL EX-SEP PRECIPITATING REAGENT (K833431)Preventive Diagnostics Corp.1984-01-13
RAICHEM HDL-CHOLESTEROL REAGENT (K830207)Reagents Applications, Inc.1983-03-21
HDL PRECIPITANT REAGENT SET (K821203)Omega Medical Electronics1982-07-13
HDL CHOLESTEROL REAGENT SET (K812839)Anco Medical Reagents & Assoc.1981-12-03
HDL CHOLESTEROL REAGENT (K812574)Pointe Scientific, Inc.,1981-09-24
HDL REAGENT (K800996)Gilford Diagnostics1980-05-14
CHOL-HDL TEST, HIGH LIPO. CHOL TEST (K792313)Sclavo, Inc.1979-12-07
LANCER HDL SEPARATION KIT (K790865)Sherwood Medical Co.1979-06-28
H-D-EL (K790372)General Diagnostics1979-05-03
A-GENT-HDL REAGENT (K790329)Abbott Laboratories1979-04-04
HDL CENTRIFIKIT (K781093)Beckman Instruments, Inc.1978-08-14
ALFATEST (K780542)Panmed, Inc.1978-05-19

Track LBR automatically

Every clearance here is in the API, with alerts when new ones post.