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510(k) K935819

QUALITY CONTROL MATERIAL (ASSAYED) by Columbia Diagnostics, Inc. — Product Code DKC

K935819 is an FDA 510(k) premarket notification submitted by Columbia Diagnostics, Inc. for the device "QUALITY CONTROL MATERIAL (ASSAYED)". The FDA issued a decision of Substantially Equivalent on March 22, 1994. The device falls under product code DKC (Alcohol Control Materials), a Class I device regulated under 21 CFR 862.3280. Columbia Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1994
Date Received
December 3, 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 Columbia Diagnostics, Inc.

  • K854119 — ACCURACY (October 25, 1985)

Other clearances for product code DKC

  • K031392 — MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (July 1, 2003)
  • 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)
  • 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