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510(k) K831956

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

K831956 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "DETERM. SIZE 72 RADIAL-HUMAN IGD". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code CZJ (Igd, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K951968 — HUMAN C1Q 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)
  • K850691 — ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (November 1, 1985)
  • K850690 — ANTISERUM TO HUMAN APOLIPOPROTEIN B (November 1, 1985)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K831961 — IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (August 11, 1983)

Other clearances for product code CZJ

  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • 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)

FDA data resources