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510(k) K053073

N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN by Dade Behring, Inc. — Product Code DEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2006
Date Received
November 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5620
Review Panel
IM
Submission Type

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Other clearances for product code DEB

  • K140664 — HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS (April 16, 2014)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K914389 — ALPHA-2 MACROGLOBULIN TEST RID KIT (December 20, 1991)
  • K896483 — QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (December 1, 1989)
  • K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (November 27, 1985)
  • K851282 — RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI (May 24, 1985)
  • K850603 — SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (March 5, 1985)
  • K812493 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO (September 23, 1981)
  • K791340 — HUMAN ALPHA2 MACROGLOBULIN (August 16, 1979)