Cleared Traditional

CALIBRATING MATERIAL, CALIBRATING STANDARDS

K031159 · Diamond Diagnostics, Inc. · Chemistry
Jun 2003
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K031159 is an FDA 510(k) clearance for the CALIBRATING MATERIAL, CALIBRATING STANDARDS, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on June 25, 2003, 72 days after receiving the submission on April 14, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K031159 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2003
Decision Date June 25, 2003
Days to Decision 72 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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