Atlas FDA

ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)

FDA 510(k) clearance K140267 · decided 2014-03-10

Clearance details

K-number
K140267
Device name
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2014-02-03
Decision date
2014-03-10
Days to decision
35 days
Clearance type
Abbreviated
Product code
JJX
Device class
1
Regulation number
862.1660
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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