Atlas FDA

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES

FDA 510(k) clearance K101425 · decided 2010-09-10

Clearance details

K-number
K101425
Device name
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2010-05-20
Decision date
2010-09-10
Days to decision
113 days
Clearance type
Traditional
Product code
LRG
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Sacramento, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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