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510(k) K981084

URISCREEN by Diatech Diagnostics,Inc. — Product Code JXA

K981084 is an FDA 510(k) premarket notification submitted by Diatech Diagnostics,Inc. for the device "URISCREEN". The FDA issued a decision of Substantially Equivalent on October 7, 1998. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1998
Date Received
March 25, 1998
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 for product code JXA

  • K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (November 30, 2001)
  • 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)
  • K950246 — MULTIPLE (IZON URINE COLLECTION KIT) (March 21, 1995)
  • K950221 — MULTIPLE (IZON BLOOD & 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