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510(k) K843839

STAT/PB REAGENT by Tri-Tech, Inc. — Product Code DOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
October 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lead, Atomic Absorption
Device Class
Class II
Regulation Number
862.3550
Review Panel
TX
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)
  • 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)
  • K813075 — TRITEC DOC TM (December 9, 1981)

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  • K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEM (October 6, 2005)
  • K971640 — LEADCARE BLOOD LEAD TESTING SYSTEM (September 9, 1997)
  • K936060 — ATOMSPEC GF BLOOD LEAD WORKSTATION (September 6, 1994)