Home / 510(k) Clearances / K843834

510(k) K843834

BACTERIURIA DETECT. DEVICE APTEK II by Applied Polytechnology, Inc. — Product Code JXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1984
Date Received
October 1, 1984
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.

  • K860483 — FILTRA-CHECK-UTI (April 4, 1986)
  • 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)
  • 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)