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FDA 510(k)

cobas HbA1c Test, cobas b 101 system

K-Number: K163633 · 2017-07-28

ApplicantRoche Diagnostics Operations
Decision Date2017-07-28
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

cobas HbA1c Test, cobas b 101 system is a medical device manufactured by Roche Diagnostics Operations. It received FDA 510(k) clearance on 2017-07-28 under approval number K163633. 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 cobas HbA1c Test, cobas b 101 system?

cobas HbA1c Test, cobas b 101 system is a medical device that received FDA 510(k) clearance on 2017-07-28. It is manufactured by Roche Diagnostics Operations. The 510(k) number is K163633.

When was cobas HbA1c Test, cobas b 101 system approved by the FDA?

cobas HbA1c Test, cobas b 101 system received FDA 510(k) clearance on 2017-07-28, under approval number K163633.

What company makes cobas HbA1c Test, cobas b 101 system?

cobas HbA1c Test, cobas b 101 system is manufactured by Roche Diagnostics Operations.

What is the FDA product code for cobas HbA1c Test, cobas b 101 system?

The FDA product code for cobas HbA1c Test, cobas b 101 system is 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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