Atlas FDA

DFC

43 FDA 510(k) clearances · Product code

60 daysmedian time to decision
268 days90th percentile
43clearances measured

FDA profile

Official device name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5600
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2024: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Lipoprotein (a) Molarity Assay (K253069)Diazyme Laboratories, Inc.2026-06-16
Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220)Roche Diagnostics Operations2025-01-24
Lp(a) Ultra (K211058)SENTINEL CH. SpA2022-12-22
Diazyme Lipoprotein (a) Assay (K180074)Diazyme Laboratories, Inc.2018-03-22
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (K123046)Siemens Healthcare Diagnostics, Inc.2012-12-20
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 (K122722)Roche Diagnostics2012-11-29
DIAZYME LP(A) ASSAY (K082488)General Atomics2009-01-13
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (K063838)Thermo Electron OY2007-09-27
QUANTIA LA(A) (K050487)Biokit, S.A.2005-04-26
K-ASSAY LP(A) CONTROLS (K023853)Kamiya Biomedical Co.2002-12-13
K-ASSAY LP(A) ASSAY (K021660)Kamiya Biomedical Co.2002-07-25
LP(A)-LATEX SEIKEN ASSAY KIT (K013359)Denka Seiken'S2002-03-08
N LATEX LP(A) (K013128)Dade Behring, Inc.2002-01-18
TINA-QUANT APOLIPOPROTEIN B VER.2 (K013206)Roche Diagnostics Corp.2001-11-16
TINA-QUANT APOLIPOPROTEIN B VER.2 (K013207)Roche Diagnostics Corp.2001-11-13
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET (K001931)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA (K001929)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO (K001933)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX (K001934)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A)/DADE DEMENSION (K001919)Wako Chemicals USA, Inc.2000-07-23
WAKO AUTOKIT LP(A)/ RA,500/1000, (K001920)Wako Chemicals USA, Inc.2000-07-23
WAKO AUTOKIT LP(A)/EXPRESS 550 (K001921)Wako Chemicals USA, Inc.2000-07-23
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB (K000121)Beckman Coulter, Inc.2000-05-17
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K001118)DiaSorin, Inc.2000-04-25
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K994110)Diasorin/American Standard Companies1999-12-21
MACRA LP(A) ENZYME IMMUNOASSAY KIT (K992665)Trinity Biotech USA1999-11-26
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K993669)DiaSorin, Inc.1999-11-17
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B (K990595)Roche Diagnostics Corp.1999-04-14
SPQ TEST SYSTEM (K982708)DiaSorin, Inc.1999-04-02
WAKO AUTOKIT LP(A) (K981446)Wako Chemicals USA, Inc.1999-03-09
APOB (K983281)Abbott Laboratories1999-01-26
IMX HOMOCYSTEINE (K980812)Axis Biochemicals, Asa1998-10-01
APO-TEK LP(A) (K970302)Perimmune, Inc.1997-11-10
WAKO AUTOKIT APO B (K954657)Wako Chemicals USA, Inc.1995-12-20
IL TEST CALIBRATION SET APO A1B (K923079)Instrumentation Laboratory CO1993-02-05
UC IMU B (K904137)Eucardio Laboratory, Inc.1990-11-21
EQUATE(TM) AQR APO AL/B DUO CONTROL (K903122)Binax, Inc.1990-08-02
QM300 CONTROL F PACK (K883712)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
QM300 CALIBRATOR F PACK (K883711)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
RAICHEM(TM) SPIA(TM) APO B REAGENTS (K872080)Reagents Applications, Inc.1987-06-15
ANTI-HUMAN LDL SERUM (K781015)Icl Scientific1978-08-14
LAS-R BETA LIPOPROTEIN TEST (K771912)Hyland Therapeutic Div., Travenol Laboratories1977-10-19
LIPPOPROTEIN ELECTROPHORESIS REAGENT SET (K771812)Gelman Instrument Co.1977-10-18

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