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510(k) K863868

IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT by Cooper Biomedical, Inc. — Product Code DFF

K863868 is an FDA 510(k) premarket notification submitted by Cooper Biomedical, Inc. for the device "IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT". The FDA issued a decision of Substantially Equivalent on February 13, 1987. The device falls under product code DFF (Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5080. Cooper Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1987
Date Received
October 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5080
Review Panel
IM
Submission Type

Other clearances by Cooper Biomedical, Inc.

  • 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)
  • K851287 — RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN (May 24, 1985)

FDA data resources