Cleared Traditional

K060678 - VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS (FDA 510(k) Clearance)

K060678 · Ortho-Clinical Diagnostics, Inc. · Microbiology device

Sep 2006

Decision

184d

Days

Class 2

Risk

K060678 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,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 14, 2006, 184 days after receiving the submission on March 14, 2006.

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

Submission Details

510(k) Number	K060678 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 14, 2006
Decision Date	September 14, 2006
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF