Atlas FDA

DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k) clearance K133728 · decided 2014-01-24

Clearance details

K-number
K133728
Device name
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2013-12-06
Decision date
2014-01-24
Days to decision
49 days
Clearance type
Traditional
Product code
CGX
Device class
2
Regulation number
862.1225
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, 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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