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510(k) K993354

K-ASSAY APO B by Kamiya Biomedical Co. — Product Code DER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1999
Date Received
October 5, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5580
Review Panel
IM
Submission Type

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  • K023853 — K-ASSAY LP(A) CONTROLS (December 13, 2002)
  • K022486 — K-ASSAY HS-CRP CONTROLS (August 14, 2002)

Other clearances for product code DER

  • K013249 — TINA-QUANT APOLIPOPROTEIN VER.2 (November 16, 2001)
  • K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3 (May 18, 2000)
  • K993345 — K-ASSAY APO AI (October 25, 1999)
  • K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (April 14, 1999)
  • K983289 — APOLIPOPROTEIN A1 (January 29, 1999)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K910553 — ROCHE APOLIPOPROTEIN STANDARD (May 8, 1991)
  • K904125 — UC IMU A (September 24, 1990)