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510(k) K905829

DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS by Kamiya Biomedical Co. — Product Code CEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
December 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ammonium Molybdate And Ammonium Vanadate, Phospholipids
Device Class
Class I
Regulation Number
862.1575
Review Panel
CH
Submission Type

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  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K050944 — K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (December 23, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C (June 27, 2003)
  • K023828 — K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULT (February 4, 2003)
  • K023853 — K-ASSAY LP(A) CONTROLS (December 13, 2002)
  • K022486 — K-ASSAY HS-CRP CONTROLS (August 14, 2002)

Other clearances for product code CEL

  • K884169 — DU PONT ANALYST THYROID ROTOR (January 24, 1989)
  • K801076 — WAKO PHOSPHOLIPIDS TEST (June 30, 1980)