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510(k) K063838

LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH by Thermo Electron OY — Product Code DFC

K063838 is an FDA 510(k) premarket notification submitted by Thermo Electron OY for the device "LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH". The FDA issued a decision of Substantially Equivalent on September 27, 2007. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. Thermo Electron OY has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2007
Date Received
December 26, 2006
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 Thermo Electron OY

  • K063145 — PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS (October 17, 2007)
  • K063705 — LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CA (October 9, 2007)
  • K063131 — CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (October 5, 2007)
  • K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (August 8, 2007)
  • K061412 — THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 (March 23, 2007)
  • K063209 — HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL (March 21, 2007)
  • K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (March 19, 2007)
  • K063647 — CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH (March 12, 2007)
  • K061107 — DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 (August 8, 2006)

Other clearances for product code DFC

  • K253069 — Lipoprotein (a) Molarity Assay (June 16, 2026)
  • 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)
  • 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)

FDA data resources