Cleared Traditional

VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT

K101921 · Ortho-Clinical Diagnostics · Chemistry
Oct 2010
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K101921 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 22, 2010, 105 days after receiving the submission on July 9, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K101921 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2010
Decision Date October 22, 2010
Days to Decision 105 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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