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510(k) K943098

HUMAN IGG SUBCLASSES ELISA COMBI KIT by Research Diagnostics, Inc. — Product Code DAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1994
Date Received
June 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5530
Review Panel
IM
Submission Type

Other clearances by Research Diagnostics, Inc.

  • K944876 — HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT (December 15, 1994)
  • K943205 — HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (September 7, 1994)

Other clearances for product code DAS

  • K982023 — PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (September 4, 1998)
  • K944876 — HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT (December 15, 1994)
  • K943205 — HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (September 7, 1994)
  • K895600 — HUMAN (IGG) SUBCLASS (EIA) KIT (November 8, 1989)
  • K790708 — ANTISERUM TO HUMAN IG G FC FRAGMENTS (August 22, 1979)
  • K790715 — ANTISERUM TO HUMAN FC (August 16, 1979)
  • K761156 — AMINOGLYCOSIDE CONTROLS (December 9, 1976)