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510(k) K860483

FILTRA-CHECK-UTI by Applied Polytechnology, Inc. — Product Code JXA

K860483 is an FDA 510(k) premarket notification submitted by Applied Polytechnology, Inc. for the device "FILTRA-CHECK-UTI". The FDA issued a decision of Substantially Equivalent on April 4, 1986. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Applied Polytechnology, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1986
Date Received
February 10, 1986
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 Applied Polytechnology, Inc.

  • K843834 — BACTERIURIA DETECT. DEVICE APTEK II (November 29, 1984)
  • K843833 — BACTERIURIA DETECT DEVICE, MULTI SAMPLER (November 29, 1984)
  • K843359 — URINE TRANSPORT KIT (September 27, 1984)
  • K843316 — INDOLE SPOT TEST KIT 270-25 (September 11, 1984)
  • K840257 — RAPID IMMUNO-ASSAY SYS (April 19, 1984)
  • K834264 — REVERSE-FLOW SYSTEM (January 13, 1984)

Other clearances for product code JXA

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

FDA data resources