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510(k) K812486

IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL by Dako Corp. — Product Code DDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1981
Date Received
August 31, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ceruloplasmin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5210
Review Panel
IM
Submission Type

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  • K020023 — DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY (February 28, 2002)
  • K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (March 3, 2000)
  • K991454 — MOUSE IGG1 NEGATIVE CONTROLS (June 21, 1999)
  • K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T (June 21, 1999)
  • 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 DDB

  • K161508 — Ceruloplasmin (January 9, 2017)
  • K122965 — HUMAN CAERULOPLASMIN KIT (June 3, 2013)
  • K053074 — N ANTISERA TO HUMAN CERULOPLASMIN (March 16, 2006)
  • K964762 — IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT (April 25, 1997)
  • K913668 — CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT (December 20, 1991)
  • K895377 — QM300 CERULOPLASMIN ANTIBODY PACK (September 21, 1989)
  • K860138 — NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM (March 28, 1986)
  • K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (November 25, 1985)
  • K852247 — LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) (July 10, 1985)
  • K851283 — RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN (May 23, 1985)