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510(k) K864006

LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST by Medical Diagnostic Technologies, Inc. — Product Code LHL

K864006 is an FDA 510(k) premarket notification submitted by Medical Diagnostic Technologies, Inc. for the device "LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST". The FDA issued a decision of Substantially Equivalent on April 20, 1987. The device falls under product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent), a Class II device regulated under 21 CFR 866.3300. Medical Diagnostic Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1987
Date Received
October 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

Other clearances by Medical Diagnostic Technologies, Inc.

  • K062229 — CTC WORKSTATION, MODEL 2200 (September 11, 2006)
  • K972209 — SPECTROLYSE HEPARIN (ANTI-IIA) (August 12, 1997)
  • K963106 — CHROMOLIZE PAI-1 KIT (November 18, 1996)
  • K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (August 14, 1996)
  • K962489 — CHROMOLIZE TPA ASSAY KIT (July 31, 1996)
  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K955738 — BIOCLOT PROTEIN S (February 29, 1996)

Other clearances for product code LHL

  • K984123 — THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. (January 11, 1999)
  • K970149 — LEGIONELLA ELISA TEST SYSTEM (June 18, 1997)
  • K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM (March 3, 1997)
  • K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (July 28, 1992)
  • K871328 — DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT (September 2, 1987)
  • K854108 — POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO (November 12, 1985)
  • K852237 — LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT (August 22, 1985)
  • K842683 — GENETIC SYS LEGIONELLA IMMUNOFLURORES (August 2, 1984)
  • K832896 — LEGIONELLA INDIRECT FLUORESCENT ANTIBOD (October 14, 1983)
  • K831760 — LEGIONELLA IFA KIT I (August 8, 1983)

FDA data resources