Atlas FDA

ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429

FDA 510(k) clearance K101854 · decided 2011-03-07

Clearance details

K-number
K101854
Device name
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2010-07-01
Decision date
2011-03-07
Days to decision
249 days
Clearance type
Traditional
Product code
CFR
Device class
2
Regulation number
862.1345
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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