Atlas FDA

AMIKACIN

FDA 510(k) clearance K970210 · decided 1997-05-01

Clearance details

K-number
K970210
Device name
AMIKACIN
Applicant
Ab Biodisk
Decision
Substantially Equivalent
Date received
1997-01-21
Decision date
1997-05-01
Days to decision
100 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Solna, SE
Third-party review
No
Expedited review
No

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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (K252062)Thermo Fisher Scientific2025-09-25
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL (K250575)Thermo Fisher Scientific2025-09-05
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (K252014)Thermo Fisher Scientific2025-08-28
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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (K250990)Thermo Fisher Scientific2025-06-30
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (K242843)Thermo Fisher Scientific2025-06-20
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856)Biomérieux2025-06-12
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (K242659)Thermo Fisher Scientific2025-05-22
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Recalls involving this device

RecordFirmDate
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 recall (Z-0817-2023)Biomerieux Inc2023-01-04