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510(k) K831959

RADIAL IMMUNO-TEST FOR HUMAN FACTOR B by Kent Laboratories, Inc. — Product Code JZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Factor B, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5320
Review Panel
IM
Submission Type

Other clearances by Kent Laboratories, Inc.

  • K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (June 1, 1995)
  • K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K950102 — HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (April 10, 1995)
  • K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (November 27, 1985)
  • K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (November 25, 1985)
  • K850690 — ANTISERUM TO HUMAN APOLIPOPROTEIN B (November 1, 1985)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K850691 — ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (November 1, 1985)
  • K831961 — IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (August 11, 1983)

Other clearances for product code JZH

  • K964843 — IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT (March 6, 1997)
  • K882623 — PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM (July 8, 1988)
  • K811740 — KALLESTAD'S ENDOPLATE FACTOR B TEST (July 16, 1981)
  • K781016 — C3PA (GBG) PROPERDIN FACTOR B (August 14, 1978)
  • K772084 — LAS-R HUMAN C3 PROACTIVATOR TEST (January 24, 1978)