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510(k) K912826

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 by Cala Diagnostics — Product Code DKC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1991
Date Received
June 26, 1991
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

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  • K864456 — CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 (May 6, 1987)

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  • K932067 — ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III (June 16, 1993)
  • K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (August 12, 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)