Cleared Special

NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

K033302 · Nichols Institute Diagnostics · Chemistry
Jan 2004
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K033302 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on January 26, 2004, 104 days after receiving the submission on October 14, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K033302 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2003
Decision Date January 26, 2004
Days to Decision 104 days
Submission Type Special
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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