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FDA 510(k)

ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM

K-Number: K080227 · 2008-05-15

ApplicantRoche Diagnostics Corp.
Decision Date2008-05-15
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K080227. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM?

ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K080227.

When did ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM receive FDA 510(k) clearance?

ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM received FDA 510(k) clearance on 2008-05-15, under 510(k) number K080227.

Who is the listed applicant for ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM?

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

What is the FDA product code for ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM?

The FDA product code for ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM is MRZ.

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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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