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510(k) K935809

CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY by Light Diagnostics — Product Code GQH

K935809 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY". The FDA issued a decision of Substantially Equivalent on May 5, 1994. The device falls under product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Light Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1994
Date Received
December 2, 1993
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 Light Diagnostics

  • K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (November 9, 1999)
  • K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (October 19, 1999)
  • K972975 — LIGHT DIAGNOSTICS RABIES DFA REAGENT (December 22, 1998)
  • K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (April 8, 1998)
  • K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (June 7, 1996)
  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • K940034 — POLIOVIRUS 2 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940017 — POLIOVIRUS 3 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940026 — POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K936254 — COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (September 8, 1995)

Other clearances for product code GQH

  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K964875 — CMV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • 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)
  • K864565 — MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT (February 19, 1987)

FDA data resources