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510(k) K860279

CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT by Bartels Immunodiagnostic Supplies, Inc. — Product Code LIN

K860279 is an FDA 510(k) premarket notification submitted by Bartels Immunodiagnostic Supplies, Inc. for the device "CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT". The FDA issued a decision of Substantially Equivalent on May 13, 1986. The device falls under product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Bartels Immunodiagnostic Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1986
Date Received
January 14, 1986
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 Bartels Immunodiagnostic Supplies, Inc.

  • K864776 — A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS (December 31, 1986)
  • K861172 — ROTAVIRUS LATEX AGGLUTINATION ASSAY (July 1, 1986)
  • K855034 — AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT (March 11, 1986)
  • K842830 — IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF (November 26, 1985)
  • K852185 — RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT (August 19, 1985)
  • K844105 — FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY (December 6, 1984)
  • K842833 — PMK PRIMARY MONKEY KIDNEY-CELLS (August 28, 1984)
  • K842834 — HEP-2 CELLS (August 28, 1984)
  • K842328 — AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN (August 3, 1984)
  • K842330 — AMER. HISTO-ID SYS PRIMARY IGA 2720-21 (August 2, 1984)

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)
  • 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)

FDA data resources