Atlas FDA

DIMENSIONS HB1C KIT, MODEL DF105A

FDA 510(k) clearance K102510 · decided 2011-05-13

Clearance details

K-number
K102510
Device name
DIMENSIONS HB1C KIT, MODEL DF105A
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2010-08-27
Decision date
2011-05-13
Days to decision
259 days
Clearance type
Traditional
Product code
LCP
Device class
2
Regulation number
864.7470
Medical specialty
Hematology
Advisory committee
Hematology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagen recall (Z-0420-2015)Siemens Healthcare Diagnostics, Inc.2014-11-21

PMA approvals by this applicant

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Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
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