Cleared Traditional

CHEMISTRY CALIBRATOR

K020454 · Jas Diagnostics, Inc. · Chemistry
Apr 2002
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K020454 is an FDA 510(k) clearance for the CHEMISTRY CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on April 8, 2002, 56 days after receiving the submission on February 11, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K020454 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2002
Decision Date April 08, 2002
Days to Decision 56 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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