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510(k) K812007

LEGIONELLA INDIRECT FLUOR. ANTIBODY by Centers for Disease Control and Prevention — Product Code LHL

K812007 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "LEGIONELLA INDIRECT FLUOR. ANTIBODY". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent), a Class II device regulated under 21 CFR 866.3300. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
July 16, 1981
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

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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)
  • K864006 — LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST (April 20, 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)

FDA data resources