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510(k) K834218

DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - by Tago, Inc. — Product Code MSJ

K834218 is an FDA 510(k) premarket notification submitted by Tago, Inc. for the device "DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -". The FDA issued a decision of Substantially Equivalent on May 11, 1984. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Tago, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1984
Date Received
December 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apolipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Tago, Inc.

  • K841734 — TAGO FIFFU-GEN, OROSOMUCOID (June 1, 1984)
  • K841265 — TAGO DIFFU-GEN C-REACTIVE PROTEIN (May 22, 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 MSJ

  • K072977 — DIAZYME APOLIPOPROTEIN A-1 ASSAY (July 16, 2008)
  • K073488 — DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX (March 7, 2008)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (March 28, 2007)
  • K063608 — DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR (February 23, 2007)
  • K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (February 15, 2000)
  • K970314 — SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS (April 21, 1997)
  • K964010 — IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHE (February 10, 1997)
  • K931777 — APO A-1 CHEMILUMINESCENCE ASSAY (August 16, 1993)
  • K925702 — NICHOLS APO B CHEMILUMINESCENCE ASSAY (December 23, 1992)
  • K923087 — IL TEST APOLIPOPROTEIN A1 (October 26, 1992)

FDA data resources