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510(k) K914777

SIGMA PROCEDURE NO. 333-UV by Sigma Diagnostics, Inc. — Product Code DML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1991
Date Received
October 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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  • K872180 — KINETIC 610 ETHANOL (July 7, 1987)
  • K863419 — EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (September 29, 1986)
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