Cleared Traditional

DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2

K120591 · Diamond Diagnostics, Inc. · Chemistry
Apr 2012
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K120591 is an FDA 510(k) clearance for the DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on April 17, 2012, 49 days after receiving the submission on February 28, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K120591 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2012
Decision Date April 17, 2012
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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