Cleared Traditional

RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER

K050100 · Bionostics, Inc. · Chemistry
Feb 2005
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K050100 is an FDA 510(k) clearance for the RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on February 25, 2005, 38 days after receiving the submission on January 18, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K050100 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2005
Decision Date February 25, 2005
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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