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FDA 510(k)

DIMENSIONS HB1C KIT, MODEL DF105A

K-Number: K102510 · 2011-05-13

ApplicantSiemens Healthcare Diagnostics
Decision Date2011-05-13
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIMENSIONS HB1C KIT, MODEL DF105A is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K102510. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSIONS HB1C KIT, MODEL DF105A?

DIMENSIONS HB1C KIT, MODEL DF105A is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K102510.

When did DIMENSIONS HB1C KIT, MODEL DF105A receive FDA 510(k) clearance?

DIMENSIONS HB1C KIT, MODEL DF105A received FDA 510(k) clearance on 2011-05-13, under 510(k) number K102510.

Who is the listed applicant for DIMENSIONS HB1C KIT, MODEL DF105A?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSIONS HB1C KIT, MODEL DF105A?

The FDA product code for DIMENSIONS HB1C KIT, MODEL DF105A is LCP.

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Related Devices (Code: LCP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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