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510(k) K851287

RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN by Cooper Biomedical, Inc. — Product Code DDG

K851287 is an FDA 510(k) premarket notification submitted by Cooper Biomedical, Inc. for the device "RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN". The FDA issued a decision of Substantially Equivalent on May 24, 1985. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. 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
Transferrin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
Submission Type

Other clearances by Cooper Biomedical, Inc.

  • K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (February 13, 1987)
  • K863868 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT (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 DDG

  • K240987 — Access sTfR (July 3, 2024)
  • K190495 — Transferrin (March 16, 2020)
  • K182095 — Tina-quant Transferrin ver.2 (urine application) (November 5, 2018)
  • K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS (February 13, 2013)
  • K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A3 (August 11, 2008)
  • K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (August 8, 2008)
  • K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (August 8, 2007)
  • K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105- (April 23, 2007)
  • K063663 — DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL (March 21, 2007)
  • K063322 — DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTR (January 24, 2007)

FDA data resources