TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET— 510(k) K912439

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K912439 for TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET, Substantially Equivalent on 1991-08-28. Applicant: Hybritech, Inc..

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1991-06-03
Decision date: 1991-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.