Cleared Traditional

DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH

K121027 · Diamond Diagnostics, Inc. · Chemistry
Dec 2012
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K121027 is an FDA 510(k) clearance for the DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on December 20, 2012, 260 days after receiving the submission on April 4, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K121027 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2012
Decision Date December 20, 2012
Days to Decision 260 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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