Atlas FDA

ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY

FDA 510(k) clearance K050632 · decided 2005-05-26

Clearance details

K-number
K050632
Device name
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
Applicant
Bayer Healthcare, LLC
Decision
Substantially Equivalent
Date received
2005-03-09
Decision date
2005-05-26
Days to decision
78 days
Clearance type
Traditional
Product code
LBS
Device class
1
Regulation number
862.1475
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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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
ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018)Bayer Healthcare, LLC2004-12-22
CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002)Bayer Healthcare, LLC1998-12-08
CIBA CORNING ACS PSA IMMUNOASSAY (P920030)Bayer Healthcare, LLC1998-12-08
CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001)Bayer Healthcare, LLC1995-12-13