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510(k) K993441

K-ASSAY ALPHA-1 AG by Kamiya Biomedical Co. — Product Code LKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1999
Date Received
October 12, 1999
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

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Other clearances for product code LKL

  • 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)
  • K831960 — TEST FOR HUMAN ALPHA ONE ACID GLYCO- (July 19, 1983)