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FDA 510(k)

cobas u 701 microscopy analyzer

K-Number: K200811 · 2020-11-06

ApplicantRoche Diagnostics
Decision Date2020-11-06
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

cobas u 701 microscopy analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K200811. The device is classified under product code LKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas u 701 microscopy analyzer?

cobas u 701 microscopy analyzer is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Roche Diagnostics. The 510(k) number is K200811.

When did cobas u 701 microscopy analyzer receive FDA 510(k) clearance?

cobas u 701 microscopy analyzer received FDA 510(k) clearance on 2020-11-06, under 510(k) number K200811.

Who is the listed applicant for cobas u 701 microscopy analyzer?

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 cobas u 701 microscopy analyzer?

The FDA product code for cobas u 701 microscopy analyzer is LKM.

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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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