OPUS (TM) HCG— 510(k) K901935

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K901935 for OPUS (TM) HCG, Substantially Equivalent on 1990-06-26. Applicant: Pb Diagnostic Systems, Inc..

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1990-04-30
Decision date: 1990-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.