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510(k) K951550

CMV BRITE ANTIGENEMIA TEST KIT by Biotest Diagnostics Corp. — Product Code LIN

K951550 is an FDA 510(k) premarket notification submitted by Biotest Diagnostics Corp. for the device "CMV BRITE ANTIGENEMIA TEST KIT". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Biotest Diagnostics Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1996
Date Received
April 4, 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 Biotest Diagnostics Corp.

  • K991650 — CMV BRITE TURBO KIT (July 12, 1999)
  • K983841 — BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG (June 9, 1999)
  • K983842 — BIOTEST ANTI-EBV RECOMBINANT, EA IGM (June 9, 1999)
  • K983839 — BIOTEST ANTI-EBV RECOMBINANT (June 9, 1999)

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)
  • K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (June 7, 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