TANDEM VISUAL HCG IMMUNOENZYMETRIC— 510(k) K834000

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K834000 for TANDEM VISUAL HCG IMMUNOENZYMETRIC, Substantially Equivalent on 1984-02-03. Applicant: Hybritech, Inc..

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1983-11-21
Decision date: 1984-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.