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510(k) K811721

H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME by Immulok, Inc. — Product Code DFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1981
Date Received
June 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kappa, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Immulok, Inc.

  • K830971 — HERPES SIMPLEX VIRUS TYPING REAGENTS (June 30, 1983)
  • K830342 — CULUTURE SET CHLAMYDIA ISOLATION AND (May 4, 1983)
  • K830250 — CVT VIRAL TRANSPORTS (February 28, 1983)
  • K823304 — RIASET PROLACTIN RIA KIT (December 22, 1982)
  • K822785 — FLUOROSET IMMUNOFLUORESCENT ANTIBODY (November 29, 1982)
  • K823055 — FLOUROSET IMMUNOFLUORESCENT ANTIBODY (November 5, 1982)
  • K822606 — CYTOMEGALOVIRUS ANTOBODY IGG (November 1, 1982)
  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)
  • K822607 — ANTINUCLEAR ANTOBODY CELL SUBSTRATE (September 17, 1982)
  • K821567 — IMMULOK CULTURESET (June 25, 1982)

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  • K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (February 23, 2024)
  • K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (January 24, 2024)
  • K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (November 18, 2022)
  • K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (September 8, 2022)
  • K220001 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (August 4, 2022)
  • K212379 — N Latex FLC kappa, N Latex FLC lambda (March 2, 2022)
  • K201496 — N Latex FLC kappa, N Latex FLC lambda (October 29, 2021)
  • K193047 — N Latex FLC kappa, N Latex FLC lambda (July 14, 2021)