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510(k) K811809

ANTI-ARRHYTHMIC CONTROL LEVELS I & II by Environmental Chemical Specialties — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 25, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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  • K801854 — SPINAL FLUID CONTROL(HUMAN) (September 16, 1980)
  • K801061 — TOTAL PROTEIN TEST (July 21, 1980)
  • K792376 — QUANTITATIVE CONTROL URINE II (HUMAN) (December 6, 1979)
  • K792375 — ELEVATED LIPID CONTROL (December 6, 1979)
  • K792374 — QUANTITATIVE CONTROL URINE I (HUMAN) (December 6, 1979)

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