Atlas FDA

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)

FDA 510(k) clearance K083339 · decided 2009-03-09

Clearance details

K-number
K083339
Device name
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2008-11-12
Decision date
2009-03-09
Days to decision
117 days
Clearance type
Traditional
Product code
CIC
Device class
2
Regulation number
862.1145
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, 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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