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510(k) K870176

GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT by Genetic Systems Corp. — Product Code LKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1987
Date Received
January 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

Other clearances by Genetic Systems Corp.

  • K891767 — GENETIC SYSTEMS MICROPLATE READER (July 25, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE WASHER (May 1, 1989)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (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)
  • K870879 — ALANINE TRANSAMINASE (ALT) TEST KIT (March 19, 1987)
  • K863566 — GSC 1000 (October 16, 1986)
  • K852237 — LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT (August 22, 1985)

Other clearances for product code LKT

  • K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)
  • K983336 — PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (March 18, 1999)
  • K943317 — PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (December 19, 1994)
  • K942173 — RSV ANTIGEN TEST (June 30, 1994)
  • K912842 — RSV-MAB TEST (December 9, 1991)
  • K912838 — BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (September 27, 1991)
  • K912371 — BIOMERIEUX RSV DIRECT IF KIT (September 23, 1991)
  • K894623 — RESPIRATORY SYNCYTIAL VIRUS (October 16, 1989)
  • K884192 — RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (November 22, 1988)
  • K882687 — ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (August 30, 1988)