Cleared Traditional

cobas u 701 microscopy analyzer

K200811 · Roche Diagnostics · Hematology
Nov 2020
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K200811 is an FDA 510(k) clearance for the cobas u 701 microscopy analyzer, a Counter, Urine Particle (Class II — Special Controls, product code LKM), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on November 6, 2020, 224 days after receiving the submission on March 27, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K200811 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2020
Decision Date November 06, 2020
Days to Decision 224 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code LKM — Counter, Urine Particle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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