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510(k) K830820

LEGIONELLA DFA KIT I by Bionetic Laboratory Products — Product Code LHL

K830820 is an FDA 510(k) premarket notification submitted by Bionetic Laboratory Products for the device "LEGIONELLA DFA KIT I". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent), a Class II device regulated under 21 CFR 866.3300. Bionetic Laboratory Products has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
March 15, 1983
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 Bionetic Laboratory Products

  • K833637 — VZV BIO-ENZABEAD SCREEN KIT (February 10, 1984)
  • K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (November 14, 1983)
  • K832069 — TOXO IPA KIT IAN INDIRECT FLUORESCENT (September 26, 1983)
  • K831760 — LEGIONELLA IFA KIT I (August 8, 1983)
  • K831133 — AMEBIASIS BIO-ENZABEAD SCREEN KIT (June 8, 1983)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)

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