Product code LBR— Clinical Chemistry
HDL CHOLESTEROL REAGENT
- Classification name
- Ldl & Vldl Precipitation, Hdl
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Total cleared
- 66
- First cleared
- Most recent
Market context for product code LBR
FDA has cleared devices under product code LBR between 1978 and 2015, filed by 52 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2015
- 2008
- 2005
- 2002
- 2001
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
Top applicants under product code LBR
Recent clearances under product code LBR
- K143691 — LDLC3 LDL-Cholesterol Gen.3
- K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
- K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
- K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
- K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
- K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- K992002 — AUTOHDL CHOLESTEROL REAGENT SET
- K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
- K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
- K980772 — HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
- K980770 — HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
- K974733 — BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
- K973369 — ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
- K971573 — N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
- K962723 — TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
- K962186 — N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
- K954179 — HDL PRECIPITATING REAGENT
- K944975 — MAGNETIC HDL CHOLESTEROL TEST
- K941744 — PBI PLUS HDL PRECIPITATING REAGENT
- K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
- K934961 — SPINPRO HDL PRECIPITATING REAGENT
- K934801 — SPINPRO HDL PRECIPITATING REAGENT
- K934039 — INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
- K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
- K924427 — SYNERMED HDL CHOLESTLEROL REAGENT KIT
- K914811 — IL TEST(TM) HDL CHOLESTEROL
- K912823 — HIGH DENSITY LIPOPROTEIN CHOLESTEROL
- K911906 — MAGNETIC HDL CHOLESTEROL TEST
- K911406 — HDL CHOLESTEROL REAGENT
- K903733 — ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
- K905284 — HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
- K904184 — BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT
- K903094 — STAT TEST HDL/CHOLESTEROL TEST KIT
- K902568 — REFLOTRON HDL CHOLESTEROL TEST TABS
- K902174 — COULTER HDL - CHOLESTEROL REAGENT
- K900120 — ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
- K895381 — HDL SINGLES
- K893966 — HDL PRECIPITATING REAGENT
- K891117 — HDL CHOLESTEROL REAGENT
- K890669 — STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
- K890023 — HDL CHOLESTEROL REAGENT (PTA/MGCL2)
- K885265 — HDL CHOLESTEROL TEST
- K883353 — IQ HDL CHOLESTEROL
- K882488 — CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
- K881244 — HDL CHOLESTEROL KIT
- K881326 — HDL CHOLESTEROL PRECIPITATING PROCEDURE
- K880176 — HDL CHOLESTEROL PRECIPITATING REAGENT
- K874820 — MULTICHEM HDL PRECIPITATING REAGENT #S0914
- K861926 — WORTHINGTON HDL PRECIPITATING REAGENT SET
- K852350 — HDL CHOLESTEROL PRETREATMENT
- K843894 — HDL PRECIPATATING REAGENT SET
- K834251 — HDL CHOLESTEROL PRETREATMENT
- K833160 — HDL EZ-TAB
- K833431 — HDL EX-SEP PRECIPITATING REAGENT
- K830207 — RAICHEM HDL-CHOLESTEROL REAGENT
- K821203 — HDL PRECIPITANT REAGENT SET
- K812839 — HDL CHOLESTEROL REAGENT SET
- K812574 — HDL CHOLESTEROL REAGENT
- K800996 — HDL REAGENT
- K792313 — CHOL-HDL TEST, HIGH LIPO. CHOL TEST
- K790865 — LANCER HDL SEPARATION KIT
- K790372 — H-D-EL
- K790329 — A-GENT-HDL REAGENT
- K781093 — HDL CENTRIFIKIT
- K780542 — ALFATEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.