FDA 510(k), K913459, THE E TEST, MODIFICATION

FDA 510(k), K913459, THE E TEST, MODIFICATION

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510(K) Number: K913459
Device Name: THE E TEST, MODIFICATION
Manufacturer: AB BIODISK
Device Classification Name: manual antimicrobial susceptibility test systems
Regulation Number: 866.1640
Classification Product Code: JWY
Date Received: 08/05/1991
Decision Date: 09/25/1991
Regulation Medical Specialty: Microbiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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