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510(k) K840404

DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO by Tago, Inc. — Product Code DAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1984
Date Received
January 31, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Haptoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5460
Review Panel
IM
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)
  • K834218 — DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - (May 11, 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 DAD

  • K993480 — K-ASSAY HAPTOGLOBIN (November 24, 1999)
  • K972639 — TINA-QUANT HAPTOGLOBIN (January 9, 1998)
  • K964301 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K963286 — IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT (October 7, 1996)
  • K952593 — N/T PROTEIN CONTROL SY/L, M AND H (July 17, 1995)
  • K915829 — IL TEST(TM) HAPTOGLOBIN (HPT) (July 29, 1992)
  • K911898 — RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (May 8, 1991)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K873866 — HAPTOGLOBIN (October 20, 1987)
  • K872717 — QM300 HAPTOGLOBIN ANTIBODY PACK (July 21, 1987)