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510(k) K031392

MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL by Medical Analysis Systems, Inc. — Product Code DKC

K031392 is an FDA 510(k) premarket notification submitted by Medical Analysis Systems, Inc. for the device "MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL". The FDA issued a decision of Substantially Equivalent on July 1, 2003. The device falls under product code DKC (Alcohol Control Materials), a Class I device regulated under 21 CFR 862.3280. Medical Analysis Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2003
Date Received
May 2, 2003
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 Medical Analysis Systems, Inc.

  • K042717 — MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL (November 5, 2004)
  • K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, (August 16, 2004)
  • K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (April 28, 2004)
  • K032826 — MAS PAR TDM (October 9, 2003)
  • K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (August 19, 2003)
  • K031890 — MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (July 16, 2003)
  • K031441 — URICHEMTRAK LIQUID ASSAYED URINE CONTROL (July 1, 2003)
  • K031364 — MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (May 30, 2003)
  • K030942 — MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (April 28, 2003)
  • K030679 — MAS LIPID LEVEL 1 AND 2 (March 14, 2003)

Other clearances for product code DKC

  • 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)
  • 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