Atlas FDA

ETEST VANCOMYCIN

FDA 510(k) clearance K980348 · decided 1998-05-29

Clearance details

K-number
K980348
Device name
ETEST VANCOMYCIN
Applicant
Ab Biodisk
Decision
Substantially Equivalent
Date received
1998-01-28
Decision date
1998-05-29
Days to decision
121 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
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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
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Recalls involving this device

RecordFirmDate
ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486 recall (Z-0831-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 recall (Z-0860-2023)Biomerieux Inc2023-01-04
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST recall (Z-1525-2017)BioMerieux SA2017-03-21