Atlas FDA

VITROS CHEMISTRY PRODUCTS DHDL SLIDES

FDA 510(k) clearance K120609 · decided 2012-09-07

Clearance details

K-number
K120609
Device name
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2012-02-29
Decision date
2012-09-07
Days to decision
191 days
Clearance type
Special
Product code
LBS
Device class
1
Regulation number
862.1475
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ortho-Clinical Diagnostics

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

Recalls involving this device

RecordFirmDate
VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 V recall (Z-0311-2014)Ortho-Clinical Diagnostics2013-11-15

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19