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510(k) K925702

NICHOLS APO B CHEMILUMINESCENCE ASSAY by Nichols Institute Diagnostics — Product Code MSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1992
Date Received
November 12, 1992
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

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Other clearances for product code MSJ

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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)
  • K923087 — IL TEST APOLIPOPROTEIN A1 (October 26, 1992)
  • K923080 — IL TEST APOLIPOROTEIN B (APO B) (October 26, 1992)