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510(k) K952246

TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT by Tri-Tech, Inc. — Product Code JXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
May 12, 1995
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 Tri-Tech, Inc.

  • K971111 — TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER (June 16, 1997)
  • K922343 — TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT (February 17, 1994)
  • K922342 — TRI-TECH INC. CUSTOM BLOOD ALCOHOL (August 27, 1993)
  • K912140 — STAIRMASTER MODEL 6000 ERGOMETER (December 17, 1991)
  • K912058 — GAUNTLET STAIR CLIMBER (October 24, 1991)
  • K912057 — 4000 PT EXERCISE SYSTEM (October 24, 1991)
  • K912056 — GRAVITRON UPPER BODY SYSTEM EXERCISER (October 24, 1991)
  • K900983 — TRI-TECH URINE SPECIMEN KIT (September 17, 1990)
  • K843839 — STAT/PB REAGENT (January 3, 1985)
  • K813075 — TRITEC DOC TM (December 9, 1981)

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)
  • 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)