OPUS IMMUNOASSAY SYSTEM— 510(k) K894159

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K894159 for OPUS IMMUNOASSAY SYSTEM, Substantially Equivalent on 1989-08-03. Applicant: Pb Diagnostic Systems, Inc..

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code KHO
Advisory panel: Clinical Chemistry
Date received: 1989-06-14
Decision date: 1989-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

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.