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510(k) K854448

AUTOSCAN W/A SYSTEM by American Micro Scan — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1985
Date Received
November 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)
  • K862140 — MICRODILUTION PANELS (July 16, 1986)
  • K861584 — GRAM NEGATIVE COMBO PANEL TYPE 3 (June 17, 1986)

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