Atlas FDA

ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING

FDA 510(k) clearance K040560 · decided 2004-07-27

Clearance details

K-number
K040560
Device name
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
Applicant
Ab Biodisk
Decision
Substantially Equivalent
Date received
2004-03-03
Decision date
2004-07-27
Days to decision
146 days
Clearance type
Traditional
Product code
NGZ
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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Recalls involving this device

RecordFirmDate
ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 recall (Z-0824-2023)Biomerieux Inc2023-01-04