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510(k) K013128

N LATEX LP(A) by Dade Behring, Inc. — Product Code DFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2002
Date Received
September 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5600
Review Panel
IM
Submission Type

Other clearances by Dade Behring, Inc.

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  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code DFC

  • K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity (January 24, 2025)
  • K211058 — Lp(a) Ultra (December 22, 2022)
  • K180074 — Diazyme Lipoprotein (a) Assay (March 22, 2018)
  • K123046 — ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (December 20, 2012)
  • K122722 — COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A (November 29, 2012)
  • K082488 — DIAZYME LP(A) ASSAY (January 13, 2009)
  • K063838 — LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (September 27, 2007)
  • K050487 — QUANTIA LA(A) (April 26, 2005)
  • K023853 — K-ASSAY LP(A) CONTROLS (December 13, 2002)
  • K021660 — K-ASSAY LP(A) ASSAY (July 25, 2002)