Atlas FDA

IQ HDL CHOLESTEROL

FDA 510(k) clearance K881891 · decided 1988-06-10

Clearance details

K-number
K881891
Device name
IQ HDL CHOLESTEROL
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1988-05-05
Decision date
1988-06-10
Days to decision
36 days
Clearance type
Traditional
Product code
LBS
Device class
1
Regulation number
862.1475
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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RecordFirmDate
HDL-Cholesterol Gen.4 (K162593)Roche Diagnostics Operations (Rdo)2016-10-19
Direct HDL Cholesterol (HDL) (K153435)Randox Laboratories, Ltd.2016-01-08
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (K132711)Carolina Liquid Chemistries Corp.2014-05-08
VITROS CHEMISTRY PRODUCTS DHDL SLIDES (K120609)Ortho-Clinical Diagnostics, Inc.2012-09-07
NMR LIPOPROFILE (R) TEST AND NMR PROFILER (K111516)Liposcience, Inc.2011-09-27
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS (K103747)Elitechgroup Seppim S.A.S.2011-08-31
EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (K111036)Medica Corporation2011-07-12
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC (K100550)Polymedco, Inc.2010-09-28
HDL CHOLESTEROL (HDLX) ASSAY (K100010)Beckman Coulter, Inc.2010-05-14
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 (K080125)Wako Chemicals USA, Inc.2008-07-18
HDL CHOLESTEROL REAGENT, MODEL 10211 (K073497)Medica Corp.2008-04-14
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS (K072395)Diazyme Laboratories2008-01-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05