Atlas FDA

VISION (TM) HDL CHOLESTEROL

FDA 510(k) clearance K871461 · decided 1987-05-14

Clearance details

K-number
K871461
Device name
VISION (TM) HDL CHOLESTEROL
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1987-04-14
Decision date
1987-05-14
Days to decision
30 days
Clearance type
Traditional
Product code
LBS
Device class
1
Regulation number
862.1475
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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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
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
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30