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510(k) K971111

TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER by Tri-Tech, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1997
Date Received
March 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Tri-Tech, Inc.

  • 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)
  • 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)

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