Cleared Traditional

K984288 - VITROS CHEMISTRY PRODUCTS PHBR SLIDES (FDA 510(k) Clearance)

K984288 · Ortho-Clinical Diagnostics, Inc. · Toxicology device
Jan 1999
Decision
56d
Days
Class 2
Risk

K984288 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS PHBR SLIDES. This device is classified as a Enzyme Immunoassay, Phenobarbital (Class II - Special Controls, product code DLZ).

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 26, 1999, 56 days after receiving the submission on December 1, 1998.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K984288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1998
Decision Date January 26, 1999
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DLZ — Enzyme Immunoassay, Phenobarbital
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.3660