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510(k) K843686

AMS ANA CARD by Vitek Systems, Inc. — Product Code JSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1984
Date Received
September 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Anaerobic Identification
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • K882960 — IDS RAPID ANA SYSTEM (August 12, 1988)
  • K855235 — DIAGNOSTIC REAGENT PET-RPLA (November 4, 1986)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)