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510(k) K962723

TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN by Trace America, Inc. — Product Code LBR

K962723 is an FDA 510(k) premarket notification submitted by Trace America, Inc. for the device "TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN". The FDA issued a decision of Substantially Equivalent on March 13, 1997. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Trace America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1997
Date Received
July 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Trace America, Inc.

  • K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (January 17, 2001)
  • K980026 — GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (March 10, 1998)
  • K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (February 2, 1998)
  • K980030 — AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (January 30, 1998)
  • K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA (January 7, 1998)
  • K974620 — AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (January 2, 1998)
  • K972297 — AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (July 17, 1997)
  • K971477 — UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (May 27, 1997)
  • K971485 — URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (May 27, 1997)
  • K961984 — PORPHOBILINOGEN (PBG) (December 10, 1996)

Other clearances for product code LBR

  • K143691 — LDLC3 LDL-Cholesterol Gen.3 (January 28, 2015)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (January 22, 2008)
  • K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (July 26, 2005)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRO (August 30, 2001)
  • K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (August 12, 1999)
  • K992002 — AUTOHDL CHOLESTEROL REAGENT SET (August 5, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (July 9, 1999)
  • K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (May 28, 1999)
  • K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (January 28, 1999)

FDA data resources