Cleared Traditional

CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250

K060140 · Diagnostic Chemicals , Ltd. · Chemistry
Apr 2006
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K060140 is an FDA 510(k) clearance for the CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on April 24, 2006, 95 days after receiving the submission on January 19, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K060140 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2006
Decision Date April 24, 2006
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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