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510(k) K042322

STERICHEK BLOOD LEAK REAGENT STRIPS by Hach Company — Product Code FJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2004
Date Received
August 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Leak, Blood
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Hach Company

  • K162471 — Hach CM130 Chlorine Monitoring System (March 30, 2017)
  • K070419 — OPACIDEN OPA REAGENT STRIPS (August 31, 2007)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)

Other clearances for product code FJD

  • K123805 — E-Z CHEK BLOOD LEAK TEST STRIPS (March 20, 2013)
  • K012115 — SERIM BLOOD LEAK TEST STRIP-2 (November 30, 2001)
  • K990206 — SERIM BLOOD LEAK TEST STRIP (April 21, 1999)