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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2020-11-06 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K200811.
When was cobas u 701 microscopy analyzer approved by the FDA?
cobas u 701 microscopy analyzer received FDA 510(k) clearance on 2020-11-06, under approval number K200811.
What company makes cobas u 701 microscopy analyzer?
cobas u 701 microscopy analyzer is manufactured by Roche Diagnostics.
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.