Lipoprotein, Low-Density, Antigen, Antiserum, Control

FDA product code DFC · 43 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5600
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-10-18 – 2026-06-16

DFC 2026-06-16

Lipoprotein (a) Molarity Assay

Applicant Diazyme Laboratories, Inc.

K number K253069

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DFC 2025-01-24

Tina-quant Lipoprotein(a) Gen.2 Molarity

Applicant Roche Diagnostics Operations

K number K241220

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DFC 2022-12-22

Lp(a) Ultra

Applicant SENTINEL CH. SpA

K number K211058

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DFC 2018-03-22

Diazyme Lipoprotein (a) Assay

Applicant Diazyme Laboratories, Inc.

K number K180074

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DFC 2012-12-20

ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR

Applicant Siemens Healthcare Diagnostics, Inc.

K number K123046

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DFC 2012-11-29

COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

Applicant Roche Diagnostics

K number K122722

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DFC 2009-01-13

DIAZYME LP(A) ASSAY

Applicant General Atomics

K number K082488

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DFC 2007-09-27

LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH

Applicant Thermo Electron OY

K number K063838

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DFC 2005-04-26

QUANTIA LA(A)

Applicant Biokit, S.A.

K number K050487

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DFC 2002-12-13

K-ASSAY LP(A) CONTROLS

Applicant Kamiya Biomedical Co.

K number K023853

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DFC 2002-07-25

K-ASSAY LP(A) ASSAY

Applicant Kamiya Biomedical Co.

K number K021660

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DFC 2002-03-08

LP(A)-LATEX SEIKEN ASSAY KIT

Applicant Denka Seiken'S

K number K013359

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DFC 2002-01-18

N LATEX LP(A)

Applicant Dade Behring, Inc.

K number K013128

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DFC 2001-11-16

TINA-QUANT APOLIPOPROTEIN B VER.2

Applicant Roche Diagnostics Corp.

K number K013206

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DFC 2001-11-13

TINA-QUANT APOLIPOPROTEIN B VER.2

Applicant Roche Diagnostics Corp.

K number K013207

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DFC 2000-07-24

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX

Applicant Wako Chemicals USA, Inc.

K number K001934

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DFC 2000-07-24

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

Applicant Wako Chemicals USA, Inc.

K number K001933

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DFC 2000-07-24

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET

Applicant Wako Chemicals USA, Inc.

K number K001931

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DFC 2000-07-24

WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA

Applicant Wako Chemicals USA, Inc.

K number K001929

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DFC 2000-07-23

WAKO AUTOKIT LP(A)/EXPRESS 550

Applicant Wako Chemicals USA, Inc.

K number K001921

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DFC 2000-07-23

WAKO AUTOKIT LP(A)/ RA,500/1000,

Applicant Wako Chemicals USA, Inc.

K number K001920

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DFC 2000-07-23

WAKO AUTOKIT LP(A)/DADE DEMENSION

Applicant Wako Chemicals USA, Inc.

K number K001919

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DFC 2000-05-17

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

Applicant Beckman Coulter, Inc.

K number K000121

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DFC 2000-04-25

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

Applicant DiaSorin, Inc.

K number K001118

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DFC 1999-12-21

LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

Applicant Diasorin/American Standard Companies

K number K994110

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DFC 1999-11-26

MACRA LP(A) ENZYME IMMUNOASSAY KIT

Applicant Trinity Biotech USA

K number K992665

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DFC 1999-11-17

LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

Applicant DiaSorin, Inc.

K number K993669

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DFC 1999-04-14

INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B

Applicant Roche Diagnostics Corp.

K number K990595

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DFC 1999-04-02

SPQ TEST SYSTEM

Applicant DiaSorin, Inc.

K number K982708

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DFC 1999-03-09

WAKO AUTOKIT LP(A)

Applicant Wako Chemicals USA, Inc.

K number K981446

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DFC 1999-01-26

APOB

Applicant Abbott Laboratories

K number K983281

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DFC 1998-10-01

IMX HOMOCYSTEINE

Applicant Axis Biochemicals, Asa

K number K980812

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DFC 1997-11-10

APO-TEK LP(A)

Applicant Perimmune, Inc.

K number K970302

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DFC 1995-12-20

WAKO AUTOKIT APO B

Applicant Wako Chemicals USA, Inc.

K number K954657

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DFC 1993-02-05

IL TEST CALIBRATION SET APO A1B

Applicant Instrumentation Laboratory CO

K number K923079

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DFC 1990-11-21

UC IMU B

Applicant Eucardio Laboratory, Inc.

K number K904137

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DFC 1990-08-02

EQUATE(TM) AQR APO AL/B DUO CONTROL

Applicant Binax, Inc.

K number K903122

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DFC 1988-09-22

QM300 CONTROL F PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K883712

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DFC 1988-09-22

QM300 CALIBRATOR F PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K883711

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DFC 1987-06-15

RAICHEM(TM) SPIA(TM) APO B REAGENTS

Applicant Reagents Applications, Inc.

K number K872080

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DFC 1978-08-14

ANTI-HUMAN LDL SERUM

Applicant Icl Scientific

K number K781015

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DFC 1977-10-19

LAS-R BETA LIPOPROTEIN TEST

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K771912

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DFC 1977-10-18

LIPPOPROTEIN ELECTROPHORESIS REAGENT SET

Applicant Gelman Instrument Co.

K number K771812

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