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510(k) K951967

HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT by Kent Laboratories, Inc. — Product Code DBA

K951967 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT". The FDA issued a decision of Substantially Equivalent on May 30, 1995. The device falls under product code DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5250. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1995
Date Received
April 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5250
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)
  • 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)
  • K850691 — ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (November 1, 1985)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (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 DBA

  • K141100 — OPTILITE C1 INACTIVATOR KIT (July 18, 2014)
  • K122304 — HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (April 15, 2013)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)
  • K011780 — K-ASSAY C1-INA (July 25, 2001)
  • K003747 — C1-INHIBITOR MICROTITER ASSAY DEVICE (March 19, 2001)
  • K965024 — N-ASSAY TIA C1-INACTIVATOR TEST KIT (July 14, 1997)
  • K960257 — N ANTISERUM TO C1 INHIBITOR (August 1, 1996)
  • K915431 — COMPLEMENT C1 INACTIVATOR KIT (January 17, 1992)
  • K872426 — CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (July 23, 1987)
  • K821898 — ORTHO CLASSICAL PATHWAY COMPL. TEST (July 16, 1982)

FDA data resources