Product code LBS— Clinical Chemistry
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- Classification name
- Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Total cleared
- 80
- First cleared
- Most recent
Market context for product code LBS
FDA has cleared devices under product code LBS between 1979 and 2016, filed by 59 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- 2016
- 2014
- 2012
- 2011
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 1999
- 1998
Top applicants under product code LBS
Recent clearances under product code LBS
- K162593 — HDL-Cholesterol Gen.4
- K153435 — Direct HDL Cholesterol (HDL)
- K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
- K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES
- K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER
- K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
- K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
- K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
- K100010 — HDL CHOLESTEROL (HDLX) ASSAY
- K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
- K073497 — HDL CHOLESTEROL REAGENT, MODEL 10211
- K072395 — DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
- K072836 — CHOLESTRAK HDL CHOLESTEROL HOME TEST
- K071706 — ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
- K062092 — PREVU POINT OF CARE SKIN STEROL TEST
- K053157 — AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
- K051962 — ULTRA HDL
- K050632 — ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
- K041928 — HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
- K041090 — HDL-EX SEIKEN ASSAY KIT
- K042006 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
- K042195 — SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
- K040767 — SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
- K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
- K033610 — HDL-CHOLESTEROL PLUS 2ND GENERATION
- K023640 — PICCOLO HDL TEST SYSTEM
- K021316 — ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
- K021671 — JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
- K014018 — CHOLESTEROL 1, 2, 3
- K014015 — OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
- K014032 — OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
- K013152 — ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
- K012286 — MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
- K991664 — LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
- K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
- K990581 — DIRECT HDL-CHOLESTEROL REAGENT
- K982539 — HDLC PRECIPITATING REAGENT
- K981224 — DIRECT HDL
- K982341 — DIRECT HDL-CHOLESTROL LIQUID
- K981899 — CARESIDE HDL-CHOLESTEROL
- K981580 — HDL
- K973988 — RDI HOMOGENEOUS HDL CHOLESTEROL TEST
- K972041 — EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
- K971162 — LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
- K971190 — N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
- K971902 — ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
- K970735 — BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K971526 — ACE HDL-C REAGENT
- K963213 — BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K954778 — CHOLESTECH LDX SYSTEM
- K943279 — ACCUMETER HDL CHOLESTEROL TEST
- K943028 — HDL QVET
- K934045 — BECKMAN HDL CHOLESTEROL REAGENT
- K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
- K905296 — CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
- K900036 — IMMUNOTECH HDL-CHOLESTEROL TEST
- K895139 — CLINISTAT HDL CHOLESTEROL REAGENT TEST
- K895851 — SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
- K894057 — QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT
- K893548 — SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
- K881891 — IQ HDL CHOLESTEROL
- K874397 — EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
- K871265 — ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
- K872050 — PARAMAX CHOLESTEROL REAGENT
- K871461 — VISION (TM) HDL CHOLESTEROL
- K864522 — ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
- K861244 — HDL/CHOLESTEROL TEST SYSTEM
- K862845 — EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
- K843029 — HIGH DENSITY LIPOPROTEIN PRECIPITATIN
- K840677 — HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
- K840676 — PDC HDL EZ-SEP CHOLESTEROL REAGENT
- K813192 — HDL-C EIKEN
- K801834 — WAKO HDL CHOLESTEROL TEST
- K801726 — HDL CHOLESTEROL TEST KIT
- K801133 — CENTRIFICHEM HDL CHOLESTEROL
- K792319 — COULTER HDL CHOLESTEROL REAG. SYSTEM
- K792183 — DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
- K791990 — TECHNICON HDL CHOLESTEROL METHOD
- K790553 — CHOLESTEROL KIT, HDL-DS
- K790281 — DIAGNOSTIC SET, LIPO-FRAX
Data sourced from openFDA. This site is unofficial and independent of the FDA.