Cleared Traditional

DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS

K133751 · Diamond Diagnostics, Inc. · Chemistry
Aug 2014
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K133751 is an FDA 510(k) clearance for the DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE 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 August 8, 2014, 242 days after receiving the submission on December 9, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K133751 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2013
Decision Date August 08, 2014
Days to Decision 242 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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