Atlas FDA

Dimension Hemoglobin A1c Assay

FDA 510(k) clearance K173909 · decided 2018-07-13

Clearance details

K-number
K173909
Device name
Dimension Hemoglobin A1c Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2017-12-22
Decision date
2018-07-13
Days to decision
203 days
Clearance type
Traditional
Product code
PDJ
Device class
2
Regulation number
862.1373
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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