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510(k) K864456

CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 by Cala Diagnostics — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1987
Date Received
November 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K930875 — CKMB CONTROL - LEVEL 1,2,3 (April 13, 1993)
  • K926015 — CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 (December 28, 1992)
  • K915503 — FIBRINOGEN FDP CONTROL (January 30, 1992)
  • K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (August 12, 1991)
  • K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (July 26, 1991)

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