Cleared Special

MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002

K060420 · Scantibodies Laboratory, Inc. · Chemistry
Mar 2006
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K060420 is an FDA 510(k) clearance for the MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, 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 March 1, 2006, 12 days after receiving the submission on February 17, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K060420 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2006
Decision Date March 01, 2006
Days to Decision 12 days
Submission Type Special
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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