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510(k) K951821

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY by Light Diagnostics — Product Code LIN

K951821 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY". The FDA issued a decision of Substantially Equivalent on June 7, 1996. The device falls under product code LIN (Antisera, Conjugated Fluorescent, 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
June 7, 1996
Date Received
April 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Conjugated Fluorescent, 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)
  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • K940017 — POLIOVIRUS 3 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940026 — POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940034 — POLIOVIRUS 2 MONOCLONAL ANTIBODY (September 12, 1995)
  • K936253 — COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY (September 8, 1995)
  • K936254 — COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (September 8, 1995)

Other clearances for product code LIN

  • K081164 — D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT (June 13, 2008)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K991650 — CMV BRITE TURBO KIT (July 12, 1999)
  • K951550 — CMV BRITE ANTIGENEMIA TEST KIT (January 30, 1996)
  • K934798 — PATHODX CYTOMEGALOVIRUS (March 25, 1994)
  • K921616 — CMV-VUE(TM) CMV ANTIGEN DETECTION KIT (August 11, 1992)
  • K912592 — CMV-EA MAB TEST (December 4, 1991)
  • K905257 — OPUS CMV TEST SYSTEM (April 17, 1991)
  • K904036 — BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN (October 16, 1990)
  • K894002 — CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY (August 10, 1989)

FDA data resources