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510(k) K011043

OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) by Osmetech — Product Code JXA

K011043 is an FDA 510(k) premarket notification submitted by Osmetech for the device "OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)". The FDA issued a decision of Substantially Equivalent on November 30, 2001. The device falls under product code JXA (Kit, Screening, Urine), 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
November 30, 2001
Date Received
April 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Urine
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)
  • K023677 — OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (January 29, 2003)

Other clearances for product code JXA

  • K981084 — URISCREEN (October 7, 1998)
  • K972676 — URINE SCREENING DEVICE (February 23, 1998)
  • K952246 — TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (June 20, 1995)
  • K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT) (April 14, 1995)
  • K950221 — MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (March 21, 1995)
  • K950246 — MULTIPLE (IZON URINE COLLECTION KIT) (March 21, 1995)
  • K934759 — CULTURIA MACCONKEY-MUG (September 9, 1994)
  • K924218 — BAC-T-SCREEN (February 3, 1993)
  • K921045 — DIASLIDE URINE CULTURING DEVICE (September 28, 1992)
  • K911846 — URI-THREE(TM), MODIFICATION (October 4, 1991)

FDA data resources