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510(k) K852237

LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT by Genetic Systems Corp. — Product Code LHL

K852237 is an FDA 510(k) premarket notification submitted by Genetic Systems Corp. for the device "LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT". The FDA issued a decision of Substantially Equivalent on August 22, 1985. The device falls under product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent), a Class II device regulated under 21 CFR 866.3300. Genetic Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1985
Date Received
May 22, 1985
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 Genetic Systems Corp.

  • K891767 — GENETIC SYSTEMS MICROPLATE READER (July 25, 1989)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (May 1, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE WASHER (May 1, 1989)
  • K891766 — GENETIC SYSTEMS MICROPLATE STRIP WASHER (May 1, 1989)
  • K890768 — PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT (March 21, 1989)
  • K873564 — GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (November 20, 1987)
  • K873542 — MICROPLATE AUTO-WASHER (MOTORIZED STAGE) (September 23, 1987)
  • K870176 — GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT (July 16, 1987)
  • K870879 — ALANINE TRANSAMINASE (ALT) TEST KIT (March 19, 1987)
  • K863566 — GSC 1000 (October 16, 1986)

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)
  • 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