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510(k) K831960

TEST FOR HUMAN ALPHA ONE ACID GLYCO- by Kent Laboratories, Inc. — Product Code LKL

K831960 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "TEST FOR HUMAN ALPHA ONE ACID GLYCO-". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code LKL (Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
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)

Other clearances for product code LKL

  • K993441 — K-ASSAY ALPHA-1 AG (November 24, 1999)
  • K964299 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K964257 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT (March 24, 1997)
  • K922417 — AL-ACID GLYCOPROTEIN RID KIT (August 20, 1992)
  • K904175 — RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT (November 13, 1990)
  • K884217 — TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN (November 4, 1988)
  • K873868 — ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (October 20, 1987)
  • K862087 — SANTEST 1AP (December 3, 1986)
  • K861336 — IAP PLATE TEST (April 25, 1986)
  • K841734 — TAGO FIFFU-GEN, OROSOMUCOID (June 1, 1984)

FDA data resources