Cleared Traditional

K060770 - VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS (FDA 510(k) Clearance)

K060770 · Ortho-Clinical Diagnostics, Inc. · Microbiology device

Sep 2006

Decision

177d

Days

Class 2

Risk

K060770 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS. This device is classified as a Hepatitis A Test (antibody And Igm Antibody) (Class II - Special Controls, product code LOL).

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on September 15, 2006, 177 days after receiving the submission on March 22, 2006.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number	K060770 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 22, 2006
Decision Date	September 15, 2006
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF