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510(k) K853532

ALCOHOL CALIBRATORS by Diagnostic Systems — Product Code DNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
August 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Ethyl Alcohol
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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Other clearances for product code DNN

  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (March 31, 1999)
  • K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (October 1, 1997)
  • K924733 — ETHYL ALCOHOL CALIBRATORS & CONTROL (December 9, 1992)
  • K882117 — ETHYL ALCOHOL STANDARD (August 4, 1988)
  • K810466 — ETHYL ALCOHOL SERUM CALIBRATOR (March 6, 1981)
  • K802620 — EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR (October 31, 1980)