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510(k) K883385

RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST by Los Alamos Diagnostics — Product Code JXA

K883385 is an FDA 510(k) premarket notification submitted by Los Alamos Diagnostics for the device "RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST". The FDA issued a decision of Substantially Equivalent on September 7, 1988. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Los Alamos Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1988
Date Received
August 9, 1988
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 Los Alamos Diagnostics

  • K896117 — MODIFIED MODEL 535(TM) LUMINOMETER (November 30, 1989)
  • K882608 — LAD MODEL 633 LUMINOMETER (August 29, 1988)
  • K881439 — MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM (April 28, 1988)
  • K874262 — LAD MODEL 735 LUMINOMETER (November 27, 1987)
  • K864202 — UTISCREEN(R) BACTERIAL ATP TEST (February 13, 1987)
  • K864201 — LAD MODEL 535 LUMINOMETER (January 13, 1987)

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