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510(k) K841734

TAGO FIFFU-GEN, OROSOMUCOID by Tago, Inc. — Product Code LKL

K841734 is an FDA 510(k) premarket notification submitted by Tago, Inc. for the device "TAGO FIFFU-GEN, OROSOMUCOID". The FDA issued a decision of Substantially Equivalent on June 1, 1984. The device falls under product code LKL (Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Tago, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1984
Date Received
April 26, 1984
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 Tago, Inc.

  • K841265 — TAGO DIFFU-GEN C-REACTIVE PROTEIN (May 22, 1984)
  • K834218 — DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - (May 11, 1984)
  • K840404 — DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO (March 9, 1984)
  • K833129 — TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 (November 21, 1983)
  • K830611 — RA SCREENING TEST (March 24, 1983)
  • K830531 — MONO SCREENING TEST (March 17, 1983)
  • K830156 — HCG SCREENING TEST (February 9, 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)
  • K831960 — TEST FOR HUMAN ALPHA ONE ACID GLYCO- (July 19, 1983)

FDA data resources