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510(k) K951966

HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT by Kent Laboratories, Inc. — Product Code JZJ

K951966 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT". The FDA issued a decision of Substantially Equivalent on June 1, 1995. The device falls under product code JZJ (Prealbumin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5060. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1995
Date Received
April 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prealbumin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5060
Review Panel
IM
Submission Type

Other clearances by Kent Laboratories, Inc.

  • 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)
  • K831959 — RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (July 19, 1983)

Other clearances for product code JZJ

  • K000661 — RANDOX PREALBUMIN (April 13, 2000)
  • K972638 — TINA-QUANT PREALBUMIN (January 9, 1998)
  • K913672 — PREALBUMIN IMMUNOLOGICAL NL TEST KIT (December 20, 1991)
  • K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (November 2, 1988)
  • K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMIN (November 2, 1988)
  • K883002 — QM300 PREALBUMIN ANTIBODY PACK (September 22, 1988)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K851912 — LASER PREALBUMIN TEST (June 21, 1985)
  • K821135 — PREALBUMIN ENZYME IMMUNOASSAY (May 5, 1983)
  • K772329 — LAS-R HUMAN PREALBUMIN TEST (February 3, 1978)

FDA data resources