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510(k) K932067

ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III by Sigma Diagnostics, Inc. — Product Code DKC

K932067 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III". The FDA issued a decision of Substantially Equivalent on June 16, 1993. The device falls under product code DKC (Alcohol Control Materials), a Class I device regulated under 21 CFR 862.3280. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1993
Date Received
April 29, 1993
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 Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX D (August 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (December 26, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (November 15, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (November 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (October 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (March 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (March 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)

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)
  • K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (August 12, 1991)
  • K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (July 26, 1991)
  • K843872 — ETHANOL CONTROLS LOW & HIGH E5133/E5258 (October 31, 1984)
  • 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