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510(k) K855091

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

K855091 is an FDA 510(k) premarket notification submitted by Sen Tech Medical Corp. for the device "CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code CDS (Electrode, Ion Specific, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Sen Tech Medical Corp. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code CDS

  • K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (January 17, 2018)
  • K040973 — BUN REAGENT (December 27, 2004)
  • K033056 — BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT (January 30, 2004)
  • K925550 — HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 (April 20, 1993)
  • K860543 — BLOOD UREA NITROGEN (BUN) TESTCARD (April 21, 1986)
  • K812308 — LANCER BUN RATE REAGENT KIT (August 31, 1981)
  • K811193 — BUN RATE REAGENT (July 10, 1981)
  • K800616 — BUN REAGENT KIT #88108 (April 10, 1980)
  • K800590 — BUN KIT (April 4, 1980)
  • K800071 — BUN REAGENT KIT (February 5, 1980)

FDA data resources