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510(k) K023677

OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) by Osmetech — Product Code LIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2003
Date Received
November 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (November 30, 2001)

Other clearances for product code LIB

  • K920416 — SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (April 8, 1992)
  • K912558 — GULL ELISAWARE (September 16, 1991)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K871559 — CELL LIFTER (May 15, 1987)
  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)