Cleared Traditional

OPUS RUBELLA TEST SYSTEM

K915870 · Pb Diagnostics, Inc. · Pathology

Mar 1992

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K915870 is an FDA 510(k) clearance for the OPUS RUBELLA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Pb Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on March 23, 1992, 83 days after receiving the submission on December 31, 1991. This device falls under the Pathology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K915870 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 1991
Decision Date	March 23, 1992
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Statement