Atlas FDA

ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY

FDA 510(k) clearance K110934 · decided 2011-08-25

Clearance details

K-number
K110934
Device name
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2011-04-04
Decision date
2011-08-25
Days to decision
143 days
Clearance type
Traditional
Product code
LCP
Device class
2
Regulation number
864.7470
Medical specialty
Hematology
Advisory committee
Hematology
Location
East Walpole, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, recall (Z-0340-2016)Siemens Healthcare Diagnostics, Inc.2015-11-25

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