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510(k) K790710

ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN by Kent Laboratories, Inc. — Product Code DDY

K790710 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN". The FDA issued a decision of Substantially Equivalent on August 3, 1979. The device falls under product code DDY (Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5620. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
April 12, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5620
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)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K850690 — ANTISERUM TO HUMAN APOLIPOPROTEIN B (November 1, 1985)
  • K831961 — IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (August 11, 1983)

FDA data resources