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510(k) K855091

CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS by Sen Tech Medical Corp. — Product Code CDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
December 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Sen Tech Medical Corp.

  • K910071 — PORTA GAS COMPRESSED GAS CYLINDER CART (March 22, 1991)
  • K854260 — CHEMPRO 1000 (November 19, 1985)
  • K851100 — CHEM PRO 1000 CHEMISTRY ANALYSIS (July 9, 1985)
  • K841575 — SENTECH'S ULAB 1000 CLINICAL CHEM. (July 6, 1984)

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  • K800616 — BUN REAGENT KIT #88108 (April 10, 1980)
  • K800590 — BUN KIT (April 4, 1980)
  • K800071 — BUN REAGENT KIT (February 5, 1980)