Cleared Traditional

ELECSYS HCG STAT CALCHECK 5

K093700 · Roche Diagnostics Corp. · Chemistry
Mar 2010
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K093700 is an FDA 510(k) clearance for the ELECSYS HCG STAT CALCHECK 5, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 4, 2010, 93 days after receiving the submission on December 1, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K093700 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2009
Decision Date March 04, 2010
Days to Decision 93 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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