Atlas FDA

HDL CHOLESTEROL (HDLX) ASSAY

FDA 510(k) clearance K100010 · decided 2010-05-14

Clearance details

K-number
K100010
Device name
HDL CHOLESTEROL (HDLX) ASSAY
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2010-01-04
Decision date
2010-05-14
Days to decision
130 days
Clearance type
Traditional
Product code
LBS
Device class
1
Regulation number
862.1475
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Brea, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Beckman Coulter

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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
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
CHOLESTRAK HDL CHOLESTEROL HOME TEST (K072836)Accutech, LLC2007-12-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Access AFP (on DxI 9000 Analyzer) (P980041/S051)Beckman Coulter, Inc.2025-11-03
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015)Beckman Coulter, Inc.2025-10-17
Access Hybritech p2PSA (P090026/S032)Beckman Coulter, Inc.2025-06-16
Access Hybritech free PSA (P970038/S046)Beckman Coulter, Inc.2025-05-15
Access Hybritech PSA (P850048/S060)Beckman Coulter, Inc.2024-09-04
Access Hybritech PSA reagent pack (P850048/S059)Beckman Coulter, Inc.2023-05-25
Access AFP Reagents on the Access Immunoassay Systems (P980041/S050)Beckman Coulter, Inc.2022-12-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057)Beckman Coulter, Inc.2022-12-16