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510(k) K924500

ANTIMICROBIAL SUSCEPTIBILITY TEST by Alamar Biosciences Laboratory, Inc. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1992
Date Received
September 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Alamar Biosciences Laboratory, Inc.

  • K941425 — ALAMAR ANTIBIOTIC SUSCEPTIBILITY (December 15, 1994)
  • K926248 — READER (May 17, 1994)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (September 23, 1993)
  • K925951 — READAR (August 31, 1993)
  • K930469 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (June 25, 1993)
  • K930055 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (April 5, 1993)
  • K922780 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (August 20, 1992)
  • K922003 — ANTIMICROBIAL SUSCETIBILITY TEST PANEL (August 19, 1992)
  • K922168 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (July 28, 1992)
  • K911558 — ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN (May 15, 1991)

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