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510(k) K831956

DETERM. SIZE 72 RADIAL-HUMAN IGD by Kent Laboratories, Inc. — Product Code CZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1983
Date Received
June 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igd, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
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)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K850690 — ANTISERUM TO HUMAN APOLIPOPROTEIN B (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 CZJ

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  • K051299 — IGD DIAGNOSTIC TEST KITS (November 23, 2005)
  • K002561 — SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (October 26, 2000)
  • K913671 — HUMAN IGD IMMUNOLOGICAL NL TEST KIT (December 2, 1991)
  • K883001 — QM300 CALIBRATOR D PACK (September 22, 1988)
  • K872834 — TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 (August 12, 1987)
  • K772327 — LAS-R HUMAN IGD TEST (February 28, 1978)