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510(k) K802930

CYTOMEGALO VIRUS & CONTROLS by Orion Diagnostica, Inc. — Product Code GQH

K802930 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "CYTOMEGALO VIRUS & CONTROLS". The FDA issued a decision of Substantially Equivalent on January 9, 1981. The device falls under product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1981
Date Received
November 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 Orion Diagnostica, Inc.

  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K904655 — PYLORISET (October 21, 1991)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

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)

FDA data resources