Cleared Traditional

WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002

K051141 · Scantibodies Laboratory, Inc. · Chemistry
Jul 2005
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K051141 is an FDA 510(k) clearance for the WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on July 26, 2005, 83 days after receiving the submission on May 4, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K051141 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2005
Decision Date July 26, 2005
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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