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510(k) K851282

RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI by Cooper Biomedical, Inc. — Product Code DEB

K851282 is an FDA 510(k) premarket notification submitted by Cooper Biomedical, Inc. for the device "RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI". The FDA issued a decision of Substantially Equivalent on May 24, 1985. The device falls under product code DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5620. Cooper Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1985
Date Received
April 1, 1985
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

Other clearances by Cooper Biomedical, Inc.

  • K863868 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT (February 13, 1987)
  • K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (February 13, 1987)
  • K863301 — DEMAND TOTAL PROTEIN (September 26, 1986)
  • K861926 — WORTHINGTON HDL PRECIPITATING REAGENT SET (June 27, 1986)
  • K854130 — DEMAND ETHYL ALCOHOL (November 5, 1985)
  • K853949 — DEMAND ACID PHOSPHATASE REAGENT (October 16, 1985)
  • K852262 — ASSIST CLINICAL CHEMISTRY ANALYZER (June 25, 1985)
  • K851285 — RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI (June 17, 1985)
  • K851284 — RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM (June 11, 1985)
  • K851286 — RADIAL IMMUNODIFFUSION PLATES C3 & C4 (June 5, 1985)

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)
  • K053073 — N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN (March 28, 2006)
  • 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)
  • 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)

FDA data resources