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510(k) K891767

GENETIC SYSTEMS MICROPLATE READER by Genetic Systems Corp. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1989
Date Received
March 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type

Other clearances by Genetic Systems Corp.

  • 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)
  • 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)
  • K852237 — LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT (August 22, 1985)

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  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)