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FDA 510(k)

ACCU-CHECK COMBO SYSTEM

K-Number: K111353 · 2012-07-17

ApplicantRoche Diagnostics
Decision Date2012-07-17
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCU-CHECK COMBO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2012-07-17 under 510(k) number K111353. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHECK COMBO SYSTEM?

ACCU-CHECK COMBO SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-17. The listed applicant is Roche Diagnostics. The 510(k) number is K111353.

When did ACCU-CHECK COMBO SYSTEM receive FDA 510(k) clearance?

ACCU-CHECK COMBO SYSTEM received FDA 510(k) clearance on 2012-07-17, under 510(k) number K111353.

Who is the listed applicant for ACCU-CHECK COMBO SYSTEM?

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

What is the FDA product code for ACCU-CHECK COMBO SYSTEM?

The FDA product code for ACCU-CHECK COMBO SYSTEM is LZG.

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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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