Home / 510(k) Clearances / K023677

510(k) K023677

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

K023677 is an FDA 510(k) premarket notification submitted by Osmetech for the device "OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)". The FDA issued a decision of Substantially Equivalent on January 29, 2003. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Osmetech has at least 3 other 510(k) clearances on record.

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

Other clearances by Osmetech

  • K061730 — OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 (August 4, 2006)
  • K052027 — OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (September 29, 2005)
  • 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)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)

FDA data resources