OPUS(R) ROZO— 510(k) K911834

Name: FDA 510(k) clearance K911834
Creator: U.S. Food and Drug Administration
Published: 1991-08-12

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K911834 for OPUS(R) ROZO, Substantially Equivalent on 1991-08-12. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LGD
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1991-04-25
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.