Atlas FDA

ETEST Telavancin (TLA) (0.002-32 ug/mL)

FDA 510(k) clearance K180936 · decided 2018-07-03

Clearance details

K-number
K180936
Device name
ETEST Telavancin (TLA) (0.002-32 ug/mL)
Applicant
Biomerieux S.A.
Decision
Substantially Equivalent
Date received
2018-04-10
Decision date
2018-07-03
Days to decision
84 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Marcy-L'Etoile, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.