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510(k) K922342

TRI-TECH INC. CUSTOM BLOOD ALCOHOL by Tri-Tech, Inc. — Product Code JKA

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 27, 1993
Date Received
May 19, 1992
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.

  • 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)
  • K912140 — STAIRMASTER MODEL 6000 ERGOMETER (December 17, 1991)
  • K912057 — 4000 PT EXERCISE SYSTEM (October 24, 1991)
  • K912058 — GAUNTLET STAIR CLIMBER (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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