Cleared Traditional

ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190

K090939 · Roche Diagnostics · Chemistry
Jun 2009
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K090939 is an FDA 510(k) clearance for the ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 18, 2009, 76 days after receiving the submission on April 3, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K090939 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2009
Decision Date June 18, 2009
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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