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510(k) K944876

HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT by Research Diagnostics, Inc. — Product Code DAS

K944876 is an FDA 510(k) premarket notification submitted by Research Diagnostics, Inc. for the device "HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT". The FDA issued a decision of Substantially Equivalent on December 15, 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
December 15, 1994
Date Received
October 3, 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.

  • K943205 — HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (September 7, 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)
  • K943205 — HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (September 7, 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