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510(k) K854119

ACCURACY by Columbia Diagnostics, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1985
Date Received
October 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Columbia Diagnostics, Inc.

  • K935819 — QUALITY CONTROL MATERIAL (ASSAYED) (March 22, 1994)

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