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510(k) K991650

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

K991650 is an FDA 510(k) premarket notification submitted by Biotest Diagnostics Corp. for the device "CMV BRITE TURBO KIT". The FDA issued a decision of Substantially Equivalent on July 12, 1999. 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
July 12, 1999
Date Received
May 13, 1999
Clearance Type
Special
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.

  • 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)
  • K951550 — CMV BRITE ANTIGENEMIA TEST KIT (January 30, 1996)

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)
  • K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (June 7, 1996)
  • 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