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510(k) K801963

CMV TEST KIT by Immuno-Diagnostic Products, Inc. — Product Code GQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

Other clearances by Immuno-Diagnostic Products, Inc.

  • K854207 — EBV(EPSTEIN-BARR VIRUS) TEST KIT (April 24, 1986)
  • K811021 — HERPES (November 5, 1981)
  • K811562 — TOXOPLASMOSIS TEST KIT (July 16, 1981)
  • K811022 — ANA TEST KIT (April 23, 1981)
  • K801959 — FTA-ABS TEST (October 23, 1980)
  • K801960 — ANTI-DS/N-DNA TEST KIT (October 10, 1980)
  • K801961 — RF-II TEST KIT (October 10, 1980)

Other clearances for product code GQH

  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K964875 — CMV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (May 5, 1994)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)
  • K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG (August 3, 1988)
  • K881932 — ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (August 1, 1988)
  • K880679 — BION CMV-G TEST SYSTEM (June 3, 1988)
  • K880290 — MICROTRAK CMV CULTURE CONFIRMATION TEST (April 19, 1988)
  • K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (December 4, 1987)
  • K873114 — CYTOMEGALOVIRUS CONTROL SLIDES (September 25, 1987)