Atlas FDA

ETEST ERTAPENEM

FDA 510(k) clearance K020748 · decided 2002-04-29

Clearance details

K-number
K020748
Device name
ETEST ERTAPENEM
Applicant
Ab Biodisk
Decision
Substantially Equivalent
Date received
2002-03-07
Decision date
2002-04-29
Days to decision
53 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
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Recalls involving this device

RecordFirmDate
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331 recall (Z-0822-2023)Biomerieux Inc2023-01-04
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative tec recall (Z-2095-2017)BioMerieux SA2017-05-03