Home / 510(k) Clearances / K915829

510(k) K915829

IL TEST(TM) HAPTOGLOBIN (HPT) by Instrumentation Laboratory CO — Product Code DAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1992
Date Received
December 30, 1991
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 Instrumentation Laboratory CO

  • K233790 — ACL TOP 970 CL (December 29, 2023)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein (September 29, 2023)
  • K223608 — GEM Premier 7000 with IQM3 (August 10, 2023)
  • K223187 — HemosIL Liquid Anti-Xa (June 23, 2023)
  • K231031 — ACL TOP Family 70 Series (June 21, 2023)
  • K223090 — GEM Premier ChemSTAT (January 27, 2023)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)

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)
  • 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)
  • K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (February 13, 1987)