Cleared Traditional

AXSYM INTACT PTH, MODEL 2G06

K020945 · Diagnostic Systems Laboratories, Inc. · Chemistry
May 2002
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K020945 is an FDA 510(k) clearance for the AXSYM INTACT PTH, MODEL 2G06, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on May 31, 2002, 67 days after receiving the submission on March 25, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K020945 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2002
Decision Date May 31, 2002
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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