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510(k) K843872

ETHANOL CONTROLS LOW & HIGH E5133/E5258 by Sigma Chemical Co. — Product Code DKC

K843872 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "ETHANOL CONTROLS LOW & HIGH E5133/E5258". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code DKC (Alcohol Control Materials), a Class I device regulated under 21 CFR 862.3280. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
October 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alcohol Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

Other clearances for product code DKC

  • K031392 — MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (July 1, 2003)
  • K935819 — QUALITY CONTROL MATERIAL (ASSAYED) (March 22, 1994)
  • K933425 — AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 (November 16, 1993)
  • K934467 — BECKMAN CX AMMONIA/ALCOHOL CONTROL (October 27, 1993)
  • K932067 — ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III (June 16, 1993)
  • K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (August 12, 1991)
  • K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (July 26, 1991)
  • K833514 — TOXI CHEM SERUM ALCOHOL CONTROL (December 8, 1983)
  • K810465 — EMIT-ST ETHYL ALCOHOL SERUM CONTROLS (March 6, 1981)
  • K802618 — EMIT-STM ETHYL ALCOHOL URINE CONTROLS (October 31, 1980)

FDA data resources