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510(k) K833514

TOXI CHEM SERUM ALCOHOL CONTROL by Fisher Diagnostics — Product Code DKC

K833514 is an FDA 510(k) premarket notification submitted by Fisher Diagnostics for the device "TOXI CHEM SERUM ALCOHOL CONTROL". The FDA issued a decision of Substantially Equivalent on December 8, 1983. The device falls under product code DKC (Alcohol Control Materials), a Class I device regulated under 21 CFR 862.3280. Fisher Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1983
Date Received
October 11, 1983
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 Fisher Diagnostics

  • K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R (June 1, 2017)
  • K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN (September 13, 2007)
  • K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS (July 18, 2006)
  • K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY C (May 10, 2006)
  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY (August 12, 2004)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)
  • K013397 — PACIFIC HEMOSTASIS REFERENCE EMULSION (February 15, 2002)
  • K010750 — PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 (September 7, 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)
  • 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)
  • K810465 — EMIT-ST ETHYL ALCOHOL SERUM CONTROLS (March 6, 1981)
  • K802618 — EMIT-STM ETHYL ALCOHOL URINE CONTROLS (October 31, 1980)

FDA data resources