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510(k) K911303

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

K911303 is an FDA 510(k) premarket notification submitted by Alamar Biosciences Laboratory, Inc. for the device "ANTIMICROBIAL AMIKACIN". The FDA issued a decision of Substantially Equivalent on April 18, 1991. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Alamar Biosciences Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1991
Date Received
March 25, 1991
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)
  • K924500 — ANTIMICROBIAL SUSCEPTIBILITY TEST (November 30, 1992)
  • K922780 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (August 20, 1992)
  • K922003 — ANTIMICROBIAL SUSCETIBILITY TEST PANEL (August 19, 1992)
  • K922168 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (July 28, 1992)

Other clearances for product code JWY

  • K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (April 21, 2026)
  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (April 17, 2026)
  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (October 2, 2025)
  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin (September 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon (September 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin (August 28, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (August 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)

FDA data resources