Cleared Traditional

OPUS(R) TOXO-G TEST SYSTEM

K921523 · Pb Diagnostics, Inc. · Microbiology

Sep 1992

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K921523 is an FDA 510(k) clearance for the OPUS(R) TOXO-G TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Pb Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on September 14, 1992, 167 days after receiving the submission on March 31, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number	K921523 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 1992
Decision Date	September 14, 1992
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement