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510(k) K900983

TRI-TECH URINE SPECIMEN KIT by Tri-Tech, Inc. — Product Code FMH

K900983 is an FDA 510(k) premarket notification submitted by Tri-Tech, Inc. for the device "TRI-TECH URINE SPECIMEN KIT". The FDA issued a decision of Substantially Equivalent on September 17, 1990. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. Tri-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1990
Date Received
March 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
HO
Submission Type

Other clearances by Tri-Tech, Inc.

  • K971111 — TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER (June 16, 1997)
  • K952246 — TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (June 20, 1995)
  • 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)
  • K912056 — GRAVITRON UPPER BODY SYSTEM EXERCISER (October 24, 1991)
  • K912058 — GAUNTLET STAIR CLIMBER (October 24, 1991)
  • K912057 — 4000 PT EXERCISE SYSTEM (October 24, 1991)
  • K843839 — STAT/PB REAGENT (January 3, 1985)
  • K813075 — TRITEC DOC TM (December 9, 1981)

Other clearances for product code FMH

  • K823763 — VARIOUS-SPECIMEN COLLECTORS (January 19, 1983)
  • K820180 — CALCULI FILTER CUP (February 5, 1982)
  • K812933 — LANCER SPECIMEN CONTAINER (November 6, 1981)
  • K802340 — SPECIMEN SET (October 10, 1980)
  • K802002 — URINE SPECIMEN CONTAINER #'S 1013-1016 (September 9, 1980)
  • K800947 — MIDSTREAM COLLECTION KIT (May 30, 1980)
  • K800309 — SPECIMEN COLLECTION PAN (February 26, 1980)
  • K800233 — ABCO MIDSTREAM URINE COLLECTION SET (February 26, 1980)
  • K792710 — PARA-PAK CLEAN VIAL (January 28, 1980)
  • K792156 — LANCER SPECIMEN CONTAINER (December 10, 1979)

FDA data resources