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510(k) K864228

APO B., IMMUNOTURBIDIMETRIC ASSAY by Intl. Diagnostic Laboratories, Ltd. — Product Code MSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1987
Date Received
October 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apolipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Intl. Diagnostic Laboratories, Ltd.

  • K864811 — ROTA-STAT (August 25, 1987)
  • K864393 — APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC (January 16, 1987)
  • K843367 — ROTAVIRUS ENZYME IMMUNOASSAY (June 13, 1985)

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  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (March 28, 2007)
  • K063608 — DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR (February 23, 2007)
  • K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (February 15, 2000)
  • K970314 — SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS (April 21, 1997)
  • K964010 — IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHE (February 10, 1997)
  • K931777 — APO A-1 CHEMILUMINESCENCE ASSAY (August 16, 1993)
  • K925702 — NICHOLS APO B CHEMILUMINESCENCE ASSAY (December 23, 1992)
  • K923080 — IL TEST APOLIPOROTEIN B (APO B) (October 26, 1992)