Cleared Traditional

VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

K063720 · Ortho-Clinical Diagnostics · Chemistry
Apr 2007
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K063720 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on April 9, 2007, 115 days after receiving the submission on December 15, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K063720 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2006
Decision Date April 09, 2007
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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