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510(k) K943205

HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) by Research Diagnostics, Inc. — Product Code DAS

K943205 is an FDA 510(k) premarket notification submitted by Research Diagnostics, Inc. for the device "HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on September 7, 1994. The device falls under product code DAS (Igg (Fc Fragment Specific), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5530. Research Diagnostics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1994
Date Received
July 5, 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)
  • K943098 — HUMAN IGG SUBCLASSES ELISA COMBI KIT (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)
  • K943098 — HUMAN IGG SUBCLASSES ELISA COMBI KIT (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)

FDA data resources