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510(k) K931192

DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY by Dako Corp. — Product Code DEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1995
Date Received
March 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lambda, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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  • K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (March 3, 2000)
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  • K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (July 22, 1998)
  • K971905 — DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLON (December 12, 1997)
  • K965022 — MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMA (November 6, 1997)
  • K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RP (June 24, 1997)

Other clearances for product code DEH

  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • K140396 — FREELITE HUMAN LAMBDA FREE KIT (April 16, 2014)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (January 30, 2004)
  • K031016 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETE (July 15, 2003)
  • K023131 — FREELITE HUMAN LAMBDA FREE KIT (January 21, 2003)
  • K010440 — FREELITE LAMBDA FREE KIT (April 26, 2001)
  • K010441 — FREELITE KAPPA FREE KIT (April 26, 2001)
  • K003671 — LAMBDA IMMAGE FREELITE KIT (February 1, 2001)
  • K002563 — SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (October 26, 2000)